Senior Manufacturing Engineer
- Process Optimization & Continuous Improvement:
- Analyze current manufacturing processes to identify inefficiencies, bottlenecks, and opportunities for improvement.
- Develop and implement strategies to reduce cycle time, scrap, and overall production costs while maintaining quality standards.
- Drive Lean Manufacturing initiatives, including Kaizen events and Value Stream Mapping.
- Validation & Documentation:
- Develop, review and approve validation protocols and (IQ/OQ/PQ) and reports for manufacturing processes, equipment, and software systems in compliance with ISO 13485 and FDA requirements.
- Ensure all validation activities and documentation comply with ISO 13485, FDA 21 CFR Part 11/820, and applicable GMP requirements.
- Lead and review any changes to process documentation, SOPs, and work instructions.
- Collaboration with Contract Manufacturers/Vendors:
- Work closely with contract manufacturers to implement engineering changes, monitor process capability (Cp/Cpk), and ensure compliance with ISO 13485 and supplier quality agreements.
- Provide technical support and guidance to ensure alignment with company standards and product specifications; oversee any process-related investigations.
- New Product Introduction (NPI):
- Support design for manufacturability (DFM) and design for assembly (DFA) during product development phases.
- Develop and validate manufacturing processes for new products, including tooling and equipment requirements.
- Support coordination of pilot runs and ensure smooth transition to full-scale production.
- Data Analysis & Reporting:
- Collect and analyze production data to monitor process performance and identify trends.
- Prepare reports and present findings to management with actionable recommendations.
- Conduct root cause analysis and implement corrective and preventive actions (CAPA) for production defects.
- Bachelor's degree in Mechanical, Industrial, or Manufacturing Engineering.
- 5+ years of experience in manufacturing engineering, preferably in a high-volume or complex production environment.
- Demonstrated track record of success in process development and Lean Manufacturing/Six Sigma methodologies.
- Advanced knowledge of manufacturing processes such as injection molding, CNC machining, and complex assembly.
- Proficiency in CAD/CAM tools (e.g., SolidWorks) and familiarity with GD&T principles.
- Strong background in Lean Manufacturing, Kaizen, and Six Sigma methodologies.
- Proficiency statistics tools (e.g., Minitab, JMP).
- Ability to conduct time studies, capacity analysis, and implement takt time improvements.
- Strong project management skills, with the ability to manage multiple projects simultaneously and drive initiatives to completion on time and within budget.
- Ability to analyze complex data sets to identify possible trends and root causes; expertise in failure mode and effects analysis (FMEA).
- Knowledge of medical device regulatory submissions (e.g., supporting DHF, DMR updates); familiar with ISO 9001 and ISO 13485 standards and requirements.
- Excellent communication and interpersonal skills for collaboration with cross-functional teams.
- Ability to work under time constraints and adapt to changing priorities in a fast-paced environment.
- Willingness to travel occasionally, as needed, to visit manufacturing partners, vendors, and processing facilities to support investigations or process changes.
- Six Sigma Green Belt or Black Belt.
- Certified Manufacturing Engineer (CMfgE).
- Background in medical devices.
- Experience with cleanroom manufacturing and/or knowledge of sterilization processes.
Recommended Jobs
Accounts Receivable Specialist
Accounts Receivable Specialist Location: Wareham, MA (position is onsite 5 days a week) Job Type: Full Time, Non-Exempt Company Summary C2 Vehicles is the largest golf cart and small-wh…
Customer Advocate I
At HCSC, our employees are the cornerstone of our business and the foundation to our success. We empower employees with curated development plans that foster growth and promote rewarding, fulfilling c…
Senior Software Engineer - Electrophysiology
Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s…
Nursing Assistant
Requisition Number: 6612 Pay Range: $18.00 - $21.00 per hour Location: Cambridge Hospital Work Days: 8a-4p 3p-11p Category: Nurse Support Department: Inpatient Units Job Type: Te…
Inpatient Child/Adolescent Psychiatrist Opportunities
Requisition Number: CHAP-1793 The NEW CHA Center of Excellence for Child & Adolescent Inpatient Mental Health Care at Somerville will provide a transformative continuum of patient- and family- cent…
Ultrasound Technologist, Ultrasound Radiology -Per-diem, Rotating Days, Eve and Nights
POSITION SUMMARY: Under the general supervision of the Ultrasound Manager and Lead Ultrasound Technologist, the Ultrasound Technologist provides skill and initiative to the department’s mission …
Digital & AI Strategy Senior Associate Save for Later Remove job
At PwC, our people in Corporate Technology Strategy consulting focus on providing strategic guidance and insights to organisations. They analyse market trends, assess business performance, and deve…
Quality Engineer
Quality Manager. Location: Woburn, MA (On-site). Reports To: Director of Operations. About Xico Lighting: Xico Lighting ( is a fast-growing manufacturer of spec-grade architectural lighti…
Radar Systems Engineer
Job Responsibilities: Architect and design advanced radar systems. Design, develop, and evaluate advanced radar signal and data processing algorithms. Develop test plans to evaluate radar sy…
Staff Software Engineer, Infrastructure
About Suno At Suno, we are building a future where anyone can make music. You can make a song for any moment with just a few short words. Award-winning artists use Suno, but our core user base consi…