Manufacturing Process Engineer
$65,000–$80,000 year
On-site · Southborough, Massachusetts, United States
Job Summary
Own and optimize manufacturing processes to ensure stability, repeatability, and performance for electromechanical medical devices in a regulated environment. Provide hands-on support on the production floor during assembly, testing, and troubleshooting; diagnose and resolve process, equipment, and product issues in real time. Lead continuous improvement initiatives using Lean/DMAIC; analyse production data to improve yield and cycle time; support root cause investigations, CAPA, and process deviations. Ensure compliance with ISO 13485 and 21 CFR 820; participate in IQ/OQ/PQ, support NPI and technology transfer, and develop SOPs and work instructions. Train production and maintenance personnel; collaborate cross-functionally with Production, Quality, Engineering, and Supply Chain. Emphasizes data-driven improvements, accountability, and teamwork.
Required Qualifications
- Technical degree with 0–5 years of experience in a manufacturing environment (medical device preferred) or 5–10 years of equivalent manufacturing experience.
- Strong written and verbal communication skills, including technical documentation.
- Ability to adapt to change and manage multiple priorities effectively.
- Demonstrated problem-solving skills with the ability to identify issues and take appropriate action.
- Strong organizational skills and ability to meet deadlines and targets.
- Proficiency in Microsoft Office applications.
- Ability to collaborate effectively with cross-functional teams.
- Ability to work collaboratively with and under the guidance of senior engineers or management.
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.