Principal Process Engineer (Medical Devices)

TL;DR

Principal Process Engineer (Medical Devices): Leading advanced manufacturing strategies and technical initiatives for life-saving medical technologies with an accent on process architecture, automation, and operational excellence. Focus on driving complex engineering projects, ensuring regulatory compliance, and mentoring cross-functional teams to accelerate product commercialization.

Location: Must be based in Danvers, Massachusetts, USA (Onsite 5 days/week)

Salary: $128,800 – $193,200 USD

Company

A global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative engineering solutions.

What you will do

• Serve as the technical authority for advanced manufacturing processes and engineering strategies.
• Lead the development and optimization of complex manufacturing processes for new and commercialized products.
• Define manufacturing architectures, technology roadmaps, and long-term process strategies.
• Drive cross-functional collaboration with R&D, Quality, Operations, and Supply Chain teams.
• Implement emerging manufacturing technologies, automation, and digital manufacturing capabilities.
• Mentor and develop engineers while providing technical leadership across the organization.

Requirements

• Bachelor's Degree with 7+ years of relevant experience OR Advanced Degree with 5+ years of experience.
• Must be authorized to work in the U.S.
• Expertise in process validation, risk management (FMEA), and quality system regulations (FDA/ISO).
• Proven ability to lead complex manufacturing technology development and commercialization efforts.
• Strong analytical skills with experience in statistical methods, DOE, and SPC.
• Excellent communication skills for stakeholder management and executive-level presentations.

Nice to have

• Experience in medical device, pharmaceutical, or biotechnology manufacturing.
• Expertise in automation, robotics, or Industry 4.0 technologies.
• Knowledge of plastics processing (injection molding, extrusion) or complex assembly.
• Lean Six Sigma Black Belt or Master Black Belt certification.

Culture & Benefits

• Competitive salary and short-term incentive plans (MIP).
• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.