Manufacturing Engineer- Medical Device- Merrimack, NH

The Manufacturing Engineer will be responsible to lead all manufacturing efforts onsite. You will support the new Manufacturing Engineering Leader.

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 Manufacturing Engineer will be responsible for:

• Support the development, optimization, and validation of manufacturing processes for vascular medical devices, ensuring alignment with FDA, ISO 13485, and internal quality standards.
• Work collaboratively with cross-functional teams, including R&D, Quality, and Operations, to assist with new product introductions (NPI), technology transfers, and production scale-up.
• Contribute to continuous improvement projects aimed at improving process efficiency, product yield, and reducing costs using lean and Six Sigma principles.
• Assist in preparing and executing process validation activities (IQ/OQ/PQ), including drafting protocols, collecting and analyzing data, and supporting report generation.
• Help troubleshoot manufacturing issues, participate in root cause investigations, and assist with implementing corrective and preventive actions (CAPAs).
• Create and update process documentation, such as manufacturing instructions, standard work, PFMEAs, and risk assessments.
• Support the selection and qualification of manufacturing equipment, working closely with senior engineers to ensure process scalability and reliability.
• Learn from and work under the guidance of senior engineers, contributing to a team-oriented environment focused on quality and operational improvement.

Profile

The successful Manufacturing Engineer will have a background as follows:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related technical field.
• 3+ 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.
• Strong communication and cross-functional leadership skills, with the ability to collaborate effectively with R&D, Quality, Regulatory, and Operations teams.

Job Offer

The Manufacturing Engineer will be offered:

• Base Salary between 90-110k (depending on years of experience)
• 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.