Manufacturing Process Engineer

Optos•Southborough, MA

9d•$65,000 - $80,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.