The Senior Manufacturing Engineer will be responsible to lead all manufacturing efforts onsite. They will be the first Manufacturing Engineer hire in the entire organization.
Client Details
A fast-growing medical device company with tremendous upside potential in a specialized market, delivering essential products for healthcare procedures worldwide. The team is expanding and actively investing in top talent during the most exciting and critical phase of their product lifecycle.
Description
The Senior Manufacturing Engineer will be responsible for:
- Lead the development, optimization, and validation of manufacturing processes for vascular devices, ensuring compliance with FDA, ISO 13485, and company quality standards.
- Collaborate closely with R&D, Quality, and Operations teams to support new product introductions (NPI), technology transfers, and scale-up for full production.
- Drive continuous improvement initiatives focused on process efficiency, yield enhancement, cost reduction, and risk mitigation using lean manufacturing and Six Sigma methodologies.
- Prepare and execute process validation activities (IQ/OQ/PQ), including writing protocols, analyzing data, and generating detailed engineering reports.
- Troubleshoot complex manufacturing issues, lead root cause investigations, and implement effective corrective and preventive actions (CAPAs) to maintain product quality and reliability.
- Develop and maintain process documentation, including manufacturing instructions, work instructions, PFMEAs, and risk assessments.
- Support equipment selection, qualification, and maintenance strategies for manufacturing lines, ensuring scalability and operational excellence.
- Mentor and provide technical guidance to junior engineers and production staff to foster a culture of innovation, quality, and continuous improvement.
Profile
The successful Senior Manufacturing Engineer will have a background as follows:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical field; Master's degree preferred.
- 5+ years of manufacturing engineering experience in the medical device industry, ideally with vascular, catheter, or minimally invasive technologies.
- Expertise in process development, validation (IQ/OQ/PQ), and scale-up for Class II/III medical devices, with a strong understanding of FDA and ISO 13485 regulations.
- Proven track record of driving continuous improvement initiatives, implementing lean manufacturing principles, and solving complex technical problems in a fast-paced environment.
- Strong communication and cross-functional leadership skills, with the ability to collaborate effectively with R&D, Quality, Regulatory, and Operations teams.
Job Offer
The Senior Manufacturing Engineer will be offered:
- Base Salary between 120-140k (depending on years of experience)
- Lead Manufacturing Engineer position onsite in Merrimack
- Full benefits package
- Small team and work environment with a lot of growth potential
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.