Bioengineering & Medical Engineering

Bioengineering & Medical Engineering

Engineering in the life sciences industry concerns the application of engineering principles and practices to living organisms, and is used in everything from stem cell engineering, biochips, biosensors, molecular biocomputing to medical imaging, infusion pumps to microkeratomes. Their task, to quote the InternationalSociety for Pharmaceutical Engineering, is to “devise new methods, technologies and products to improve our health and fight against disease.”

Thanks to an impeccable reputation for producing top quality products and a well-regulated environment, the phrase ‘Made in Germany’ has become synonymous with quality and innovation. Due to this reputation, Germany
has become the largest medical device sector in Europe and the third largest in the world. The sector takes up 10.2% of global tech production with most recent reports showing €27.6bn in sales, €17.6bn of which was in exports (medicaldevicenetwork.com).

The coming years will see the medical device sector grow in importance - by 2035,Germany’s over-65 population will reach 24 million, representing a third of the domestic population, while the over-50 demographic will represent at least half. As such, digital health companies in Germany have become heavily focused on the ‘silver economy’, working on developing medical devices which will improve the quality of life for an ageing population. This will lead to a huge increase in the number of jobs created in the field.

A pharmaceutical engineer can be involved in every process of the production of a drug, right down to designing the packaging it comes in to ensure quality management, tamper indication and safety. This is a growing sector of the industry and its continued growth is sure to provide an abundance of jobs for the more creatively inclined pharmaceutical engineers. Theglobal pharmaceutical packaging marketsize was estimated at €82.6bn now, and is projected to expand at a CAGR of 8.3% until 2025. The increasing demand for pharmaceuticals owing to increase in healthcare coverage, growing ageing population, and an increase in non-communicable disease in emerging economies are the major drivers for the pharmaceutical packaging market.

​EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place the best talent in the engineering sector in Germany and across Europe.


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Benefits of working with us

Experience

We have over a decade’s worth of experience as a leading talent partner in Life Sciences & Pharma.

Network

A vast, global network of the best, in-demand professionals, working with the world’s largest Life Sciences institutions, to take drugs, devices and therapeutic applications through from conception to completion.

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Our award-winning talent specialists offer bespoke, tailored guidance on the latest hiring trends and industry news to help you achieve your goals.

Engineering Jobs

LIMS Informatics Engineer

Exciting Opportunity for an Informatics Engineer! We're seeking a proactive and innovative Informatics Engineer to spearhead the implementation of innovative solutions in the life sciences industry. In this role, you'll be the driving force behind documenting, troubleshooting, and optimizing customer experiences, both remotely and on-site, ensuring seamless operations in informatics. Position: Informatics Engineer Location: Tokyo/Osaka Responsibilities: Oversee the execution of Informatics solution projects, including documentation and implementing solutions. Resolving customer issues and enhancing customer relationships, centering efforts on ensuring customer success. Delivering top-notch service and support to customers. Requirements: High school or above (Bachelor's degree is preferred). Fluent in Japanese (JLPT N1 or native level), and English reading and writing skills. 3+ years of experience in Project Management, particularly in the life sciences industry (in LIMS, IT knowledge). Deep knowledge of Windows servers Understanding of Oracle, GMP requirements 当社は、ライフサイエンス業界で最先端のソリューションの実装を先導する積極的で革新的な情報工学エンジニアを求めています。この役割では、リモートとオンサイトの両方で顧客体験の文書化、トラブルシューティング、最適化を推進し、情報工学におけるシームレスな運用を確保します。 職種: 情報工学エンジニア 場所: 東京/大阪 責任: 文書化とソリューションの実装を含む情報工学ソリューション プロジェクトの実行を監督します。 顧客の問題を解決し、顧客関係を強化し、顧客の成功を確実にすることに注力します。 顧客に最高のサービスとサポートを提供します。 要件: 高校以上 (学士号が望ましい)。 日本語が堪能 (JLPT N1 またはネイティブ レベル)、英語の読み書きスキル。 特にライフサイエンス業界でのプロジェクト管理 (LIMS、IT 知識) における 3 年以上の経験。 Windows サーバーに関する深い知識 Oracle、GMP 要件の理解

Negotiable
Tokyo
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Opérateur CNC/Décolleteur

Nous recherchons actuellement un opérateur CNC avec des compétences en mécanique, tournage ou usinage pour l'un de nos clients, basé dans la partie francophone de la Suisse. Notre client est une entreprise internationale spécialisée dans les dispositifs médicaux. Tâches: Préparation des machines, y compris la programmation et le réglage des paramètres CNC Opération des machines CNC pour assurer la production efficace et de haute qualité Supervision de la production pour garantir la conformité aux normes de qualité Communication des points importants pour le prochain quart de travail Promotion du travail d'équipe et de l'entraide entre collègues Profil recherché: Formation en mécanique, mécanicien-décolleteur ou équivalent Expérience significative en usinage, avec une maîtrise des commandes CNC Connaissance des décolleteuses Traub, Citizen et Tornos Swissnano serait un atout Détails supplémentaires: Date de début: dès que possible Langues: Français Horaire: 2x8 alterné, début à 05h00 et à 13h15 - 13h15 à 21h00 Lieu: Villeret, Bern Si cette opportunité vous semble intéressante et que vous répondez aux critères requis, n'hésitez pas à nous contacter en nous envoyant votre CV.

Swiss Franc58500 - Swiss Franc68000 per annum
Schweizer-Reneke
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Production Engineer - SG

Our client is a leading global pharmaceutical company, dedicated to advancing treatments for patients with various disorders and providing healthcare solutions for the wider community. Position: Senior Production Engineer (Pharmaceutical) Location: Singapore Role Description: Supervise research and development manufacturing operations and provide technical expertise. Develop manufacturing methods to transfer to new facilities, and assisting in method validation. Prepare and train operators in Standard Operating Procedures (SOPs). Document process safety and risk assessments. Requirements: Experience in a regulated manufacturing industry (pharmaceutical or biotechnology preferred). Master's or PhD in Chemistry/Chemical Engineering/Pharmaceutical Sciences. 5+ years of experience in formulation development. Strong understanding of GMP, process development, and validation, and pharmaceutical quality systems. Background in pharmaceutical formulation development and technology transfer.

Negotiable
Singapore
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Field Service Engineer

Come be a part of a pioneering company reshaping the landscape of life sciences! Our esteemed client, a forefront player in analytical equipment, is dedicated to catalyzing significant advancements in biological research and healthcare. Position: Field Service Engineer Location: Tokyo or Yokohama, Japan Key Responsibilities: Deliver top-tier technical assistance for state-of-the-art medical equipment across your assigned region. Lead on-site installations, maintenance, and repairs of analytical instruments, ensuring uninterrupted functionality for our esteemed clientele. Tackle technical challenges head-on, providing solutions that go above and beyond expectations. Cultivate synergy with interdisciplinary teams to propel innovation and excellence in our offerings. Candidate Requirements: 3+ years of experience as a Field Service Engineer. Knowledge and background in the medical device or life sciences domain. Fluency in Japanese (Business-Native level, JLPT N1), proficient English reading and writing skills. Possession of a valid driver's license in Japan. Preferred Qualifications: Bachelor's degree or higher in sciences or engineering. ライフサイエンスの世界を一変させる先駆的な企業の一員になりませんか。分析機器の第一線で活躍する当社の尊敬すべきクライアントは、生物学研究とヘルスケアの大きな進歩を促進することに尽力しています。 職種: フィールド サービス エンジニア 勤務地: 東京/横浜 (日本) 主な職務: 担当地域全体で最先端の医療機器に関するトップクラスの技術支援を提供します。分析機器の現場での設置、保守、修理を主導し、尊敬すべきお客様の機能が中断されないようにします。技術的な課題に正面から取り組み、期待を上回るソリューションを提供します。学際的なチームとの相乗効果を生み出し、当社の製品における革新と卓越性を推進します。 応募者の要件: フィールド サービス エンジニアとして 3 年以上の経験。 医療機器またはライフサイエンス分野の知識と経歴。 日本語が堪能であること (ビジネス ネイティブ レベル、JLPT N1)、英語の読み書き能力が優れていること。 日本で有効な運転免許証を所持していること。 望ましい資格: 理学または工学の学士号以上。

Negotiable
Tokyo
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Field Service Engineer

Overview: Are you a passionate Field Service Engineer looking for your next permanent challenge? My client is seeking an experienced individual to their dynamic team, delivering exceptional service and support within the diagnostics sector. This role is tailored for those who thrive on ensuring equipment runs at peak performance while fostering strong client relationships. Responsibilities: Deliver exceptional technical support for cutting-edge medical equipment in your designated region Oversee on-site installations, repairs, and maintenance of diagnostic equipment to ensure seamless operations for clients Investigate and resolve troubleshooting issues thoroughly, providing solutions that go beyond expectations Cultivate collaboration with interdisciplinary teams to drive innovation and excellence for products and services Requirements: Demonstrated success as a Field Service Engineer in fast-paced environments, showcasing adaptability and resilience. Deep understanding and experience within the diagnostics or medical device industry, demonstrating a passion for advancing healthcare Successfully completed training as a medical technician or obtained a degree in electrical engineering/medical engineering or comparable training Fluent in German and English Benefits: Competitive compensation package Desirable collaborative team culture Career development opportunities

Negotiable
Würzburg
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CQV Engineer

Amazing opportunity with one of our Global Bio-Pharmaceutical company in the German speaking part of Switzerland looking for CQV Engineer. Summary The CQV Engineer is primarily responsible for the preparation and the execution of the CQV activities as per below responsibilities. Responsibilities Execution of the following activities for the relevant systems in accordance with Project procedures/guidelines: System Boundary development + approval. Design Qualification preparation, execution and approval. Includes release for IQ. GMP-RA's. Commissioning preparation, execution and approval. Includes vendor supervision on their testing scope and quality. Installation Qualification preparation, execution and approval. Includes release for OQ. Operational Qualification preparation, execution and approval. Includes release to OPS. Provide support in execution of Design Qualification for other direct impact systems. Provide support in the implementation of the Installation Commissioning process in accordance with Project procedures/guidelines. Shall be able to work / support another C&Q activity if deemed necessary. Carry out shift work, where required. Available for travel to vendors / contractors, were required Candidate profile: Minimum requirements: Minimum Bachelor's degree in Life Sciences or Engineering Minimum of 2+ years of experience in commissioning / qualification / validation (DQ, IQ, OQ, Commissioning) activities in the pharmaceutical/biotech industry. Proven Process or Utility Equipment experience (either DSP, USP, Bioconjugates or Clean Utilities) Minimum 2+ years of experience in commissioning / qualification / validation of Clean Utilities Systems. Experience with DeltaV (Emerson). Fluent English language written and verbal communication skills. cGMP knowledge and knowledge of regulatory requirements. Able to work with minimum oversight fulfilling deliverable within target dates For further information about this position please apply *Please note, only those with the right to work in Switzerland can apply! (Unfortunately we do not sponsor work visa)

Negotiable
Switzerland
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MES Engineer

Amazing opportunity with one of our Global Bio-Pharmaceutical company in the German speaking part of Switzerland looking for MES Engineer. Senior MES Engineer who can lead, plan, install and guarantee the functionality of a MES system with significant experience in MES, Windows Server, MSSQL, Visualisation and a high-level programming language to join our Lonza talent community. Support the standardisation and optimisation of the MES standard library and are jointly responsible for training and knowledge transfer within the team. Job Requirement Ensuring the cGMP-compliant documentation (Validation, SOP, etc.) in cooperation with the plant engineer and system group. Support and troubleshoot of technical issues of the existing MES systems in site Visp. Perform routine maintenance and updates to ensure the stability and optimal performance of the MES Syncade system. Development and optimisation of Electronic Work Instructions, Behaviours and Function Modules. Constantly improving procedures and processes in compliance with the safety, hygiene, environmental and quality requirements in the area of responsibility. Recipe Authoring Experience in Delta V & Syncade system Job profile: Completed studies in Automation Engineering Min 2- 5 plus year's Professional experience in Life Science environment A clear view of priorities and deadlines Team-oriented personality who attaches great importance to a reliable, solution-oriented and careful way of working For further information about this position please apply *Please note, only those with the right to work in Switzerland can apply! (Unfortunately we do not sponsor work visa)

Negotiable
Switzerland
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Field Application Scientist

Our client is seeking a Field Applications Scientist to provide technical support for the bioprocess product lines. This role involves using expertise in cell culture perfusion to assist customers and our sales team. Responsibilities: Support sales and product management by providing technical assistance for our product lines. Respond to customer queries, conduct seminars, perform product demonstrations, troubleshoot, and gather customer feedback. Develop and execute project plans using our technologies to meet customer requirements. Participate in or lead projects. Requirements: Bachelor's degree or higher in sciences or engineering. 5+ years of experience in upstream biopharmaceutical processes. Knowledge of perfusion and intensified processes for various bioproducts is beneficial. Familiarity with scale-up, tech transfer, and cGMP requirements. Experience in upstream cell culture is advantageous. 当社のクライアントは、バイオプロセス製品ラインの技術サポートを提供するフィールド アプリケーション サイエンティストを募集しています。この役割には、細胞培養灌流の専門知識を使用して顧客と当社の営業チームを支援することが含まれます。 責任: 当社の製品ラインの技術サポートを提供することで、営業と製品管理をサポートします。 顧客からの問い合わせに応答し、セミナーを開催し、製品のデモンストレーションを行い、トラブルシューティングを行い、顧客からのフィードバックを収集します。 当社の技術を使用して、顧客の要件を満たすプロジェクト計画を策定し、実行します。 プロジェクトに参加または主導します。 要件: 理学または工学の学士号以上。 上流バイオ医薬品プロセスで 5 年以上の経験。 さまざまなバイオ製品の灌流および強化プロセスに関する知識があると有利です。 スケールアップ、技術移転、および cGMP 要件に精通していること。 上流細胞培養の経験があると有利です。

Negotiable
Tokyo
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Field Service Engineer

Join our team at a groundbreaking company at the forefront of reshaping the biotech sector! Partnered with a leading medical device corporation, we are committed to revolutionizing biological research and healthcare. Position: Field Engineer Location: Osaka, Japan Responsibilities: Deliver exceptional technical support for cutting-edge medical equipment in your designated region. Oversee on-site installations, repairs, and maintenance of biotechnology equipment to ensure seamless operations for our esteemed clients. Investigate and resolve troubleshooting issues thoroughly, providing solutions that go beyond expectations. Cultivate collaboration with interdisciplinary teams to drive innovation and excellence in our products and services. Requirements: Demonstrated success as a Field Service Engineer in fast-paced environments, showcasing adaptability and resilience. Deep understanding and experience within the medical device or life sciences industry, demonstrating a passion for advancing healthcare. Fluent in Japanese (Business-Native level, JLPT N1) with proficient English reading and writing skills. Possession of a valid driver's license in Japan. Qualifications: Bachelor's degree or higher in engineering or a related field. バイオテクノロジー分野の改革の最前線に立つ画期的な企業で、当社のチームに加わってください。大手医療機器企業と提携し、当社は生物学研究とヘルスケアの革命に取り組んでいます。 職種: フィールド エンジニア, 大阪、日本 責任: 担当地域の最先端の医療機器に関する優れた技術サポートを提供します。 バイオテクノロジー機器の現場での設置、修理、メンテナンスを監督し、当社の大切なお客様のためにシームレスな運用を実現します。 トラブルシューティングの問題を徹底的に調査して解決し、期待を超えるソリューションを提供します。 学際的なチームとのコラボレーションを促進し、当社の製品とサービスの革新と卓越性を推進します。 要件: フィールド サービス エンジニアとして、適応性と回復力を発揮し、ペースの速い環境で成功を収めた実績があること。 医療機器またはライフ サイエンス業界に関する深い理解と経験があり、ヘルスケアの進歩に情熱を持っていること。 日本語が堪能であること (ビジネス ネイティブ レベル、JLPT N1)、英語の読み書きスキルに優れていること。 日本で有効な運転免許証を所持していること。 資格: 工学または関連分野で学士号以上を取得していること。

Negotiable
Osaka
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Field Automation Engineer

Exciting new opportunity - Automation Engineer in Japan! Are you ready to embark on a dynamic journey in the world of automation engineering? Our client is seeking a talented individual to join as a Field Automation Engineer (FAE) based in Japan. As an integral member of our team, you will be at the forefront of our mission to deliver cutting-edge automation solutions to their esteemed customers in the region. This is a great platform for growth, innovation, and collaboration. Join the team and be part of a global leader in bioprocessing solutions, where your contributions will make a meaningful impact on scientific advancements worldwide. About the Role: As a Field Automation Engineer, you will take charge of all automation activities at customer sites, including installation, maintenance, validation, and servicing systems such as bioprocessing equipment, Chromatography, and spectrophotometers. Your expertise will be instrumental in providing seamless automation and integration support to the valued clients in Japan, with occasional travel within APAC. Key Responsibilities: Provide technical support and hands-on assistance for equipment repair, preventive maintenance, and systems automation. Conduct onsite support for installation, validation, and troubleshooting systems. Serve as the technical authority within the service team and provide automation support activities at customer sites. Collaborate closely with commercial and product teams to address customer needs and escalate issues promptly. Maintain accurate documentation of service activities and communicate effectively with internal and external stakeholders. Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). Qualifications: Bachelor's degree or higher in software, systems, electronics, or automation engineering. 5+ years of experience in automation of scientific instruments, laboratories, or bioprocess settings. Proficiency in software and automation tools, especially in Programmable Logic Controller (PLC). Fluency in Japanese and English (written and spoken). Strong GMP knowledge and experience.

Negotiable
Tokyo
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Auditor

Medical Device Auditor Job type: Permanent Location: Home Based (USA) A leading global Medical Device Notified Body is currently seeking to hire a Medical Device Auditor to join their growing team in the North America. You will play a key role in the company's growth strategy and success of their business. Additionally, you will be able to make an immediate impact on their North American operations with leading MedTech manufactures. Key responsibilities of the Medical Device Auditor include: Perform regulatory audits of Clients, as well as evaluations of regulatory submissions which include Technical File Review, according to EU directives (MDR) and the MDSAP Reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body Provide project management for North American-based Clients. This will include the issuing of quotes, coordinating multiple projects, coordinating audit team and interacting directly with the customer Key requirements of the Medical Device Auditor include: The ideal candidate should have a strong background in the production, validation, engineering or development side of the Medical Device industry Direct involvement in the Quality Management System (QMS) of a Medical Manufacturer. Experience in either Active or Non-Active products is relevant At least 4 years hands-on medical device experience in order to qualify for Notified Body Auditor status Regular travel 3-5 nights a week is required across the North American regions University degree in Engineering or Sciences; Biomedical, Electrical, Industrial, Biology, Chemistry or Physics Please apply directly or reach out or call +1 646-253-0243

£80000 - £80001 per annum
United States of America
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Quality Systems Engineer

Summary: As the Quality Systems Engineer, you will ensure the implementation, maintenance, monitoring, and reporting of designated quality system processes to ensure their sufficiency and continual enhancement in an ISO13485 environment. With a primary focus on nonconformance and Corrective and Preventive Action (CAPA) quality systems, this role spearheads and assists in investigations, root cause analyses, corrective actions, and the management of nonconformance and CAPA processes. The ideal candidate possesses a robust background in quality systems, adept problem-solving abilities, and a steadfast commitment to upholding quality standards within the medical device industry. Key Responsibilities: Graphics and Labeling Requirements: Evaluates, edits, and formulates label content according to customer specifications and company protocols. Assumes responsibility for label management and reconciliation processes, ensuring accurate documentation of label application and disposal. Assists Speed to Market teams during product transfers and collaborates with Production teams on product alterations. Updates job jackets, MOM, and related documents to implement product modifications based on reviewed revisions. Reviews and supports the assessment of material non-conformances, ensuring proper segregation, disposition, and corrective actions before material release. Investigates and addresses customer returns, complaints, and support requests regarding product conformity, implementing necessary corrective actions promptly. Review and investigates requested or assigned Corrective Action Requests (CARs) and Corrective and Preventive Actions (CAPAs). Supports or conducts compliance audits of Quality System processes, manufacturing areas, and documentation as directed. Presents audit findings to process or area management and company leadership as required. Assists the Quality System Manager in overseeing external audits from customers and regulatory bodies. Manages equipment and gauge calibration resources, ensuring compliance with calibration procedures. Supports the maintenance and control of measurement equipment, conducting periodic inspections for usability and addressing user queries or concerns. Provides support for equipment preventive maintenance scheduling and work standard enforcement. Collaborates with the organization to develop work standards in line with production transfer and improvement initiatives. Facilitates air, water, and surface monitoring for viable and particulate counts, coordinating with external suppliers for cleanroom and HEPA testing. Contributes to Quality objectives relevant to job responsibilities. Undertakes additional duties as assigned by the immediate supervisor. Job Closing Responsibilities: Reviews MOM for customer documentation requirements, excluding references to CoCs. Qualifications: Education and Experience: Bachelor's Degree in Life Sciences or a related technical discipline (e.g., biomedical engineering) or field. Minimum of 5 years of experience in an ISO 13485 environment. Minimum of 5 years of direct experience in nonconformance and CAPA investigation within the medical device industry. Previous experience supporting and facilitating internal and external audits within the medical device field. Certificates, Licenses, Registrations: Certification as a quality auditor or similar industry certification. Benefits: Full-time team members become eligible for benefits starting the first day of the month following 30 days of employment. These include: Health Insurance: High Deductible Health Plan (HDHP) with Health Savings Account (HSA) - with an employer contribution of $1,040 annually. High Preferred Provider Organization (PPO) Low Preferred Provider Organization (PPO) Flexible Spending Account (FSA) Dental Insurance Vision Insurance Basic Life Insurance (Employer-paid) Supplemental Life Insurance Short-term Disability Insurance (Employer-paid) Long-term Disability Insurance 401(k) Plan with a 4% Employer Match Paid Time Off (accrued at 120 hours per year)* 9 Paid Holidays Access to Continuing Education and Seminar Programs Employee Assistance Program (EAP) Fitness Room Access

US$100000 - US$115000 per year
Minneapolis
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