Senior Engineer , Device Development

Location:
Boston, MA or New Haven, CT

• Deep understanding of the device design: development/identification of critical dimensions, systems engineering, sensitivity analysis, tolerance stack‑ups, and technical assessments via analytical and empirical means. Devices of interest include pre‑filled syringes, autoinjectors, pen injectors, and on‑body delivery systems.
• Manage facets of technical development, including interactions with suppliers, CMOs, technology vendors, and internal cross‑functional teams.
• Oversee characterization and design verification testing, determine relevant success criteria, and develop, qualify, and transfer the appropriate methods.
• Author technical documentation in support of the development process or design control deliverables.
• Root cause analysis of product or process deviations or failures, using Six Sigma tools to manage investigations.
• Communicate learnings and educate other team members on methods and analytical approaches.
• Act independently within team expectations, coordinate with functional leadership to identify priorities, and complete tasks under accountability while balancing high autonomy.
• Demonstrate technical rigor and creativity, continuous learning and improvement, and alignment to customer needs and value creation.
• Demonstrate strong and clear accountability for the successful and timely completion of designated tasks.

• BS Degree in Mechanical, Biomedical, Chemical Engineering, Materials Science, Engineering or closely related disciplines.
• 6+ years of experience as a product design/development engineer in the medical device or pharmaceutical industries, with experience in combination products (prefers prefilled syringes, autoinjectors, pen injectors, and on‑body injectors).
• Experience developing products or implementing product changes through a structured, phase‑gated product development process.
• Demonstrated experience covering all phases of the Design Control process.
• Experience in a technical, product development role on a cross‑functional team; leadership role preferred.
• Understanding of medical device product development risk management methodologies.
• Expertise in statistical analysis (Minitab, Crystal Ball, etc.), analytical tools (e.g., FEA), benchtop testing (e.g., Zwick, fixture design), and root cause analysis/investigation.
• Strong team‑building and collaboration skills across the organization, and intellectual curiosity to deeply understand technical concepts.
• Knowledge of performance and regulatory compliance requirements for medical devices and combination products (EU and FDA): IEC 62366, ISO 11608 series, ISO 14971, IEC 60601 series, FDA QSR 21 CFR Part 4 and 820 / ISO
  13485 quality system requirements.

• Master’s, or PhD Degree in Engineering (Mechanical, Biomedical, Chemical or Materials Science and Engineering) or closely related disciplines.
• 6-10+ years experience in medical device/container closure development with 2+ years in combination product commercialization.

Date Posted

05-Jun-2026

Closing Date

02-Aug-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.