Medical Device - Manufacturing Engineer - Billerica, MA

Manufacturing Engineer

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.

Job Description:

• 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.

Requirements:

• 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.

Professional Development:

• 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.