Senior Manufacturing Engineer

Senior Manufacturing Engineer (Medical Device Experience)

Overview: The Senior Manufacturing Engineer will play a crucial role in bridging the gap between Research & Development (R&D), Pilot Production, and full-scale commercial manufacturing. This role involves extensive collaboration across various departments to ensure the seamless transition of new medical products from early development stages to market readiness. The position focuses on ensuring that both design and manufacturing processes are well-defined, scalable, and adhere to the highest standards of quality and compliance.

Key Responsibilities:

• Design and optimize manufacturing processes for both capital and disposable medical devices, emphasizing assembly, testing, sterilization, and packaging to ensure cost-effectiveness and compliance.
• Generate detailed production assembly and component drawings.
• Apply Design for Manufacturing (DFM), Six Sigma, and LEAN methodologies to enhance manufacturability and cost efficiency.
• Evaluate and select contract manufacturing partners based on their ability to meet quality, cost, and timeline requirements.
• Facilitate strong partnerships with contract manufacturers to develop efficient and reliable production methods.
• Serve as the primary point of contact between the project team and external manufacturing entities, ensuring aligned manufacturing strategies and activities.
• Conduct thorough reviews of product specifications and CAD drawings to guarantee adherence to industrial standards.
• Lead the validation and characterization of manufacturing processes, including conducting detailed experiments and tests to establish process capabilities and control.
• Develop and maintain essential documentation such as manufacturing instructions, equipment guidelines, and quality control measures.

Results Expected:

• Efficiently manage and update all design for manufacturability tasks, ensuring all processes are up to date and reflect current best practices.
• Maintain and periodically revise the Bill of Materials (BOM), work instructions, and process flow documents.
• Oversee the creation and updates to process failure mode and effects analysis (pFMEA).

Qualifications:

• A Bachelor’s degree or higher in Mechanical Engineering.
• Over five years of experience in the engineering of manufacturing processes within the medical device sector, with a significant portion dedicated to new product introduction and design transfer.
• Expertise in SolidWorks for complex assemblies and tooling designs.
• Experience with contract manufacturing, especially in the production of medical capital equipment and components.
• Demonstrated ability in process validation, design transfer, and working with sterilizable polymers and advanced fabrication techniques.
• Proficiency in applying DFM, Six Sigma, LEAN, cGMP, and process validation principles.
• Skilled in using Microsoft Office Suite and statistical tools such as Minitab or JMP for process analysis.

Preferred Skills:

• Certifications in Lean and/or Six Sigma methodologies.

Work Environment:

• This position requires full-time onsite presence.

Pro034 Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.