Gentuity, LLC · 12 hours ago
Senior Process Engineering Manager
Sudbury,MA,US
Full-time
Onsite
Senior Level
7+ years expGentuity, LLC is focused on process development in the medical device industry, and they are seeking a Senior Process Engineering Manager to oversee the transition from R&D to manufacturing. This role involves managing process validation, optimizing manufacturing processes, and leading continuous improvement initiatives while collaborating with cross-functional teams.
Health CareManufacturingMedical Device
Responsibilities
Manage process development, scale-up, and design transfer from R&D to Manufacturing, ensuring design intent, manufacturability, and validation readiness
Oversee equipment qualification and process validation (IQ/OQ/PQ), including protocol development, execution, data analysis, and reporting to confirm process capability before launch
Design and optimize manufacturing processes, tooling, fixtures, and cleanroom layouts to improve safety, quality, and productivity
Drive continuous improvement initiatives that enhance yield, efficiency, quality, and cost using methods such as SPC, Cpk analysis, and GR&R
Collaborate cross-functionally with R&D, Quality, and Manufacturing to resolve process performance issues and support product builds, changes, and enhancements
Lead root cause analysis and corrective actions for production problems, non-conformances, and customer complaints
Develop and maintain process documentation, work instructions, and risk management files, ensuring proper operator and technician training
Monitor and report Manufacturing and Quality metrics, supporting CAPAs, investigations, and regulatory compliance
Develop the technical capabilities and skills of your team of engineers, motivating them to high performance. Identify and help address gaps in knowledge and skills
Provide subject matter expertise in plastics extrusion, injection molding, packaging, adhesives, coatings, laser fibers, and statistical analysis
Support supplier selection and qualification for manufacturing processes and equipment, and coordinate on supply chain or component obsolescence issues
Communicate project status, risks, and recommendations to management proactively
Perform additional duties as required to support organizational success
Qualification
Required
Minimum of 7 years of manufacturing engineering experience in a medical device production industry with a minimum of 2 years of supervisory experience
Experience with ISO 13485 and FDA Quality System Regulations
Experience with Minitab or other statistical evaluation software
Lean Six Sigma training or certification and knowledge of statistical data analysis techniques (DOE, GR&R, Cpk, SPC)
Risk management experience (DFMEA, PFMEA)
CAD experience (preferably SolidWorks)
Demonstrated project management skills with ability to prioritize multiple concurrent projects in a fast-paced environment and identify/resolve issues as they arise with minimal supervision
Cross functional team player with a strong work ethic, strong engineering and problem-solving skills, creative thinking, good decision-making skills, high attention to detail, effective interpersonal skills and excellent verbal/written communication skills
Bachelor's degree in mechanical or biomedical engineering (or related Engineering degree) plus minimum of 7 years of experience working in an FDA/ISO regulated medical device/medical equipment industry or equivalent education and years of experience
Preferred
PD experience is preferred
Experience with biomedical fiber optic components and processing is a plus
Company
Gentuity, LLC
Based in Sudbury, MA., Gentuity is a commercial-stage medical technology firm dedicated to developing next-generation intravascular imaging devices capitalizing on today’s best-in-class technologies.
51-200 employees
H1B Sponsorship
Gentuity, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
David W. Kolstad
Chief Executive Officer
Christopher Petersen
Co-founder and Senior Vice President
Recent News
2025-09-09
Medical Product Outsourcing
2025-08-13
Company data provided by crunchbase