A fast-growing biotechnology client is seeking a high-caliber Senior Engineer II, Device Development to provide immediate technical leadership in the development and lifecycle management of patient-centric drug delivery systems. Reporting directly to the Senior Director of Device Development, this role accelerates the execution of both pipeline innovations and commercial product sustaining engineering across autoinjectors, pre-filled syringes, and wearable devices. The ideal candidate brings deep design control expertise, technical rigor, and a proven ability to translate complex clinical needs into safe, reliable combination products that transform patient outcomes.
location: Cambridge, Massachusetts
job type: Contract
salary: $100 - 130 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Design Controls & Documentation: Author and maintain comprehensive Design History Files (DHF) and Device Master Records (DMR), establishing robust design inputs, output specifications, verification/validation strategies, and complete traceability.
- Risk Management & Quality Alignment: Translate clinical use scenarios and human factors observations into comprehensive risk assessments per ISO 14971, ensuring direct alignment with design input requirements and risk-based test protocols.
- Technical Root Cause Investigation: Lead complex technical investigations and engineering failure analyses to resolve device and component issues, evaluating supplier deviations, customer complaints, and change control impact assessments.
- External Partner & CDMO Oversight: Direct technical workstreams with external partners, including component manufacturers, contract research organizations (CROs), and contract manufacturing organizations (CMOs); oversee protocol execution, data analysis, and report generation at external laboratories.
- Sustaining & NPI Engineering: Execute engineering analyses-including first-principles physics modeling, FEA, and empirical testing-to support both new product introductions (NPI) and lifecycle management changes for commercialized delivery platforms.
- Regulatory Compliance & Strategy: Prepare rigorous technical content and justifications for regulatory submissions (e.g., 510(k), PMA, MAA) and directly support responses to global regulatory inquiries.
- Process Modernization & Innovation: Leverage modern engineering frameworks (DFSS, DFM, DOE) and integrate AI-enabled workflow tools to streamline problem-solving, optimize technical documentation, and drive pipeline efficiency.
qualifications:
Required:
- Bachelor of Science in Biomedical, Mechanical, Electrical, or a related engineering discipline.
- 6+ years of medical device or combination product development experience, including 3+ years specifically focused on drug delivery platforms (e.g., autoinjectors, pre-filled syringes, wearable injectors, pen injectors, or reconstitution systems).
- Thorough mastery of combination product regulatory standards and quality frameworks, including 21 CFR Part 4, ISO 13485, ISO 14971, 510(k)/PMA pathways, and EU MDR/MDD requirements.
- Proven track record in prototype evaluation, engineering analysis (FEA, first-principles modeling), test method development, and hands-on laboratory troubleshooting.
- Strong cross-functional communication skills with demonstrated success managing technical deliverables with third-party suppliers and CDMOs.
- Master's degree or Ph.D. in Biomedical, Mechanical, or Electrical Engineering.
- Experience utilizing requirements management and traceability tools such as JAMA, IBM DOORS, Polarion, or CodeBeamer.
- Practical fluency with AI tools to accelerate engineering workflows, data analysis, and technical documentation.
- End-to-end experience guiding a drug-device combination product from early-stage design concept through commercial market entry.
- Expertise in connected health platforms, electromechanical drug delivery devices, and handheld digital technologies.
- Demonstrated mastery of Design for Six Sigma (DFSS), Design for Manufacturability (DFM), and Design of Experiments (DOE) methodologies.
skills: Medical Device, Medical Device Regulation (MDR)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
