Medical Device - Manufacturing Engineer - Billerica, MA

My client is seeking a Manufacturing Engineer to play a key role in developing next-generation cardiology devices. You will oversee manufacturing processes, support early-stage production builds, and collaborate with cross-functional teams to ensure the efficient production of life-saving medical devices.

Client Details

My client is an innovative medical device startup dedicated to developing cutting-edge solutions aimed at improving the quality of life for patients with heart failure. With a small, dynamic team, each member plays a key role in driving the evolution of both the product and the company. Employees can expect a fast-paced environment where they take on diverse responsibilities, from handling essential tasks to working on the next generation of life-changing medical devices.

Description

Main Duties and Responsibilities Include:

• Take a hands-on role in developing next-generation cardiology devices and implants.
• Oversee product manufacturing in a cleanroom environment, supporting various production activities.
• Provide engineering support for the manufacturing of catheters and implants.
• Develop and refine manufacturing processes for new products, offering design-for-manufacturing insights.
• Lead the design and development of early-stage and production manufacturing fixtures and equipment.
• Manage early production builds (feasibility, DV, Process Validation) for products in development.
• Guide the training and implementation of new manufacturing processes within the production team.
• Write and execute process validations (IQ/OQ/PQ) and PFMEAs.
• Identify and collaborate with contract manufacturers and suppliers for early-stage production, helping to scale up and support full-scale manufacturing.
• Assist with product logistics to ensure timely delivery and supply to the field.

Profile

The Successful Candidate:

• Bachelor's degree or higher in Engineering (Mechanical, Manufacturing, Biomedical) or a related field.
• Experience with disposable medical devices, catheters, or implant manufacturing.
• 5-10 years of experience in the medical device industry.
• Background in disposable medical devices, catheters, or implant manufacturing.
• Strong verbal and written communication skills.
• Ability to communicate effectively across various organizational levels.
• Familiarity with EO sterilization processes.
• Proficient in creating and maintaining organized, accurate records and reports.
• Experience with 3D CAD software (e.g., Solidworks).
• Proficient in Microsoft Office Suite.
• Experience with statistical analysis tools, such as Minitab.
• Strong organizational and prioritization skills.
• 3D printing experience is a plus.
• Machine shop experience is a plus.
• LEAN Manufacturing experience is a plus.

Job Offer

What's To Offer:

• Competitive salary ranging from $125K to $145K, based on experience.
• Comprehensive benefits package, including health, dental, and vision coverage.
• 401(k) plan with company matching to support your long-term financial goals.
• Opportunities for professional growth and career advancement in a dynamic work environment.
• A collaborative, inclusive workplace where your contributions are valued.

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.