Principal Mechanical Engineer

Principal Mechanical Engineer - Onsite in Portsmouth NH

This is an exciting opportunity for a Principal Mechanical Engineer with a medical device and/or pharmaceutical background to have a strategic impact at the clinical stage. You'll provide technical leadership in the design, development, verification, and validation of drug-device combination products such as needle-based injection systems and combination products. The ideal person drives innovative, manufacturable, and regulatory compliant designs from concept through design transfer and commercial production. This requires strong knowledge in material compatibility, EL, biocompatibility, and patient safe device performance.

Responsibilities

• Provide technical leadership for the end to end design and development of mechanical components and assemblies for drug/device combination products. Lead material selection, compatibility assessments, and design activities related to EL, biocompatibility, and container-closure integrity for combination products.
• Apply advanced Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to optimize designs for performance, cost, reliability, and high-volume production.
• Lead human factors engineering activities, including user needs research, usability studies, and integration of use-related risks. Lead risk management activities in accordance with ISO 14971, with focus on combination product risks, material compatibility, EL, and biocompatibility.
• Ensure all design and development activities comply with ISO 13485, 21 CFR Part 820 (cGMP), ISO 11608 (needle-based injection systems), 21 CFR Part 4 (combination products), ISO 10993 (biocompatibility), and applicable EL standards (e.g., USP , PQRI, FDA guidance).Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for manufacturing processes and equipment.
• Perform detailed tolerance analysis, finite element analysis (FEA), material compatibility studies, and design verification testing.
• Provide technical mentorship and leadership to junior and senior engineers; review and approve key design deliverables, including human factors and EL documentation.
• Collaborate closely with Quality Assurance, Regulatory Affairs, Manufacturing, Clinical, and Analytical Chemistry teams to support design transfer, scale-up, and post-market surveillance.
• Prepare and maintain Design History Files (DHF), technical files, and regulatory documentation for audits and submissions (510(k), NDA, 505(b)(2)).

Qualifications

• Bachelor’s degree in Mechanical Engineering, Materials Engineering, or a related field.
• 10-15 years of progressive experience in mechanical design and product development.
• 7 years in the medical device or combination product industry.
• Principal-level technical leadership, leading complex projects and engineering teams.
• Expertise in drug-device combination products, with hands-on experience addressing EL, material compatibility, and ISO 10993 requirements.
• Experience in Human Factors Engineering for medical devices: planning and executing usability studies and integrating human factors into design controls and risk management.
• Direct, working knowledge of cGMP (21 CFR Part 820), ISO 13485, ISO 14971, ISO 11608 (Needle-based injection systems), Combination Product regulations, ISO 10993 Biocompatibility, and related EL standards.
• Proven leading IQ/OQ/PQ validation activities for manufacturing processes and equipment.
• Proficiency with 3D CAD software (SolidWorks) and associated PDM/PLM systems.
• Proficient in design controls, tolerance analysis, FEA, SPC, and capability studies.
• Experience designing autoinjectors, pen injectors, or prefilled syringe-based delivery systems.
• Knowledge of primary container systems and their integration with autoinjectors.
• Lean Manufacturing, Six Sigma, or Design for Six Sigma experience.
• Familiarity with high-volume assembly automation and process development.
• Success supporting NDA, 505(b)(2), or other combination product regulatory submissions.