Medical Device Engineer

3 weeks ago


Billerica, Massachusetts, United States Michael Page Full time
Cardiology Manufacturing Engineer Role

We are seeking an experienced Manufacturing Engineer to join our innovative medical device startup, specializing in developing cutting-edge cardiology solutions. The ideal candidate will oversee manufacturing processes, collaborate with cross-functional teams, and contribute to the development of life-saving devices.

About Us

MICHAEL PAGE is a leading provider of talent acquisition services, dedicated to delivering exceptional professionals to drive business success. Our clients trust us to find top talent, and we strive to exceed their expectations every time.

Job Highlights

  • 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

Responsibilities:

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

Requirements:

  1. Bachelor's degree or higher in Engineering (Mechanical, Manufacturing, Biomedical) or a related field.
  2. Experience with disposable medical devices, catheters, or implant manufacturing.
  3. 5-10 years of experience in the medical device industry.
  4. Strong verbal and written communication skills.
  5. Ability to communicate effectively across various organizational levels.
  6. Familiarity with EO sterilization processes.
  7. Proficient in creating and maintaining organized, accurate records and reports.
  8. Experience with 3D CAD software (e.g., Solidworks).
  9. Proficient in Microsoft Office Suite.
  10. Experience with statistical analysis tools, such as Minitab.
  11. Strong organizational and prioritization skills.
  12. 3D printing experience is a plus.
  13. Machine shop experience is a plus.
  14. LEAN Manufacturing experience is a plus.


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