Senior Mechanical Design Engineer

Senior Mechanical Design Engineer (Medical Device)

📍 Portsmouth, NH | 💼 Direct Hire | 🏢 100% On‑Site

The Opportunity

We are seeking a highly experienced Senior Mechanical Design Engineer to join a tight‑knit, collaborative engineering team focused on developing innovative medical devices. This is a hands‑on leadership role where you’ll not only drive complex product design from concept through production, but also mentor and develop a growing team of engineers.

This role is ideal for someone who thrives in a team‑oriented environment, enjoys problem solving at a high level, and takes ownership of delivering high‑quality, patient‑safe products in a regulated space.

What You’ll Do

• Lead the end‑to‑end design and development of complex mechanical and electromechanical medical devices
• Focus on plastic components and assemblies (injection molding, housings, fluid paths, multi‑part systems)
• Apply DFM/DFA principles to ensure scalable, high‑volume manufacturing success
• Drive risk management activities (FMEA, hazard analysis) in accordance with ISO 14971
• Lead and execute IQ/OQ/PQ validation efforts for manufacturing processes, tooling, and equipment
• Collaborate cross‑functionally with Quality, Regulatory, Manufacturing, and Clinical teams
• Support design transfer, scale‑up, and post‑market activities
• Perform tolerance analysis, material selection, FEA, and design verification testing
• Maintain and support Design History Files (DHF) and regulatory documentation
• Identify cost savings and design improvements without compromising quality or performance
• Use data and analytics to monitor performance and drive continuous improvement

Leadership & Team Impact

• Mentor and support junior engineers and designers
• Lead with curiosity and a problem‑solving mindset
• Contribute to a culture of collaboration, accountability, and continuous learning
• Balance hands‑on design work with team leadership and development

What You Bring

• Bachelor’s degree in Mechanical Engineering (Master’s preferred)
• 10 years of experience in mechanical/product design
• 5 years in medical device engineering
• Strong experience with plastic part design for injection molding
• Hands‑on knowledge of:
• cGMP (21 CFR Part 820)
• ISO 13485
• ISO 14971
• ISO 11608
• Proven experience leading IQ/OQ/PQ validation efforts
• Proficiency in SolidWorks or similar CAD tools
• Strong understanding of design controls, SPC, and capability studies
• Experience mentoring or leading engineering teams
• Excellent communication and collaboration skills

What Sets You Apart

• Naturally curious, analytical, and solution‑oriented
• Comfortable working in a small, highly collaborative team environment
• Passion for mentoring others while still contributing technically
• Ability to manage multiple priorities and drive results

Compensation & Benefits

• 💰 $150K base salary bonus potential
• 🩺 100% company‑paid medical, dental, and vision (for you and your dependents)
• 💼 401(k) with company match
• 🌴 Discretionary Time Off (DTO) company holidays
• 📈 Professional development & growth opportunities
• 📊 Potential equity/stock participation