Senior Manufacturing Engineer (Medical Devices)

Harris Fields Search Partners is leading the search for a Senior Manufacturing Engineer to join a cutting-edge team in Boston. This role involves collaborating with world-class hospitals to transform medical research into commercially viable products. The ideal candidate will have hands-on experience with cart systems, console operations, and electromechanical devices. You will play a crucial role in supporting the transition from R&D to commercial manufacturing, ensuring processes are efficient, scalable, and compliant with regulatory standards. This is full-time 6-month contingent contract engagement which may be extended based on contractor performance and continued business need.

Key Responsibilities:

• Develop and optimize manufacturing processes for medical devices, focusing on assembly, lot release testing, sterilization, and packaging.
• Create and maintain production-level assembly and part drawings for components and sub-assemblies using SolidWorks.
• Lead Design for Manufacturing (DFM) reviews and incorporate Six Sigma and LEAN principles to enhance efficiency and reduce costs.
• Collaborate with contract manufacturers to ensure quality, cost-efficiency, and regulatory compliance.
• Act as a liaison between R&D, Supplier Development, Quality, and Operations to support the design transfer and commercialization of products.
• Oversee pFMEA processes, develop process validations, and maintain BOMs, work instructions, and other key manufacturing documents.

Qualifications:

• Bachelor’s degree in Mechanical Engineering or related field.
• 5+ years of experience in medical device manufacturing, including at least 3 years in new product development and process validation.
• Strong proficiency in SolidWorks, with experience in designing assemblies.
• Expertise in LEAN, Six Sigma, and Design for Manufacturing principles.
• Experience with contract manufacturers and process optimization in medical device production.
• Knowledge of cGMP, FDA standards, and sterilizable materials is preferred.

Nice to Have:

• LEAN or Six Sigma certifications are a plus.
• Experience in catheter fabrication and sterilizable polymers.

Equal Opportunity Employment:

Harris Fields Search Partners and its clients are committed to creating an inclusive and diverse workforce. Equal employment opportunities are provided to all employees and applicants regardless of race, color, religion, sex, national origin, disability, or veteran status. Diversity and inclusion are core principles of our hiring process, and we welcome applications from individuals of all backgrounds.