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Manufacturing Process Engineer
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Groe Advisors LLC
Marlborough, MA (In Person)
Full-Time
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Job Description
Manufacturing Process Engineer at Groe Advisors LLC Manufacturing Process Engineer at Groe Advisors LLC in Marlborough, Massachusetts Posted in 5 days ago.
Type:
full-timeJob Description:
ROLE SUMMARY
The Manufacturing Process Engineer is responsible for owning and improving manufacturing processes to ensure safe, compliant, and efficient production of electromechanical medical devices in a regulated manufacturing environment, with a strong sense of ownership and accountability for process performance. This role requires a hands-on, floor-focused engineer who is actively engaged in product builds, process troubleshooting, equipment performance, and continuous improvement initiatives, working cross-functionally with Production, Quality, and Engineering to drive process capability, resolve technical issues, and support new product introductions (NPI). The position plays a key role in advancing Lean manufacturing and fostering a One Team culture, delivering practical, data-driven process improvements that enhance quality, efficiency, and reliability.ESSENTIAL DUTIES AND RESPONSIBILITIES
- Own and optimize manufacturing processes to ensure stability, repeatability, and performance.
- Provide hands-on support during assembly, testing, and troubleshooting on the production floor to resolve issues in a timely manner.
- Diagnose and resolve process, equipment, and product-related issues in real time.
- Lead and drive continuous improvement initiatives using Lean/DMAIC principles.
- Analyse production data to drive improvements in yield, cycle time, and process efficiency.
- Support root cause investigations, CAPA activities, and process deviations.
- Ensure compliance with
ISO 13485, 21 CFR
820, and internal quality systems.- Participate in process validation activities (IQ/OQ/PQ).
- Support new product introduction (NPI) and technology transfer to manufacturing.
- Develop and maintain SOPs, work instructions, and process documentation.
- Train production and maintenance personnel on processes, equipment, and best practices.
- Collaborate cross-functionally with Production, Quality, Engineering, and Supply Chain teams.
- Promote a culture of continuous improvement, accountability, and teamwork.
MINIMUM 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.
HIGHLY BENEFICIAL SKILLS
- Working knowledge of 21 CFR 820 and
ISO 13485
regulatory standards.- Experience with continuous improvement methodologies, including DMAIC, FMEA, structured problem solving, and SPC.
- Hands-on experience supporting product assembly, testing, and process development within a manufacturing environment.