Senior Manufacturing Engineer

Job Title: Senior Manufacturing Engineer
Job Location: Mansfield, MA
Job Duration: 11-12 Months (possibility of extension)
Payrate: $50.00 - $64.90/hr.

Job Summary:

• The Senior Manufacturing Engineer I will work within the Client CSS Operations Engineering organization to support the development, transfer to manufacturing, launch readiness, and production stability requirements for existing products and processes.
• This position will provide technical expertise and project management in the areas of medical device manufacturing process development and validation, DFM, COGs management, design transfer, production planning, and production stability.

Supervision Received:

• Reports to the Director of Operations Engineering.

Essential Duties and Responsibilities:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities include:

• Work in cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to develop and sustain surgical products for the neurosurgical medical device industry.
• Serve as a manufacturing process technical expert providing engineering knowledge and oversight to plan and develop manufacturing processes, identify, specify, and procure manufacturing equipment, develop operation plans to support product development and transfer, resolve manufacturing and quality-related problems, and interface with production facilities as the Voice of Operations on projects.
• Lead cross-functional projects, including developing and executing project plans and milestones, controlling/adjusting project plans, developing alternate pathways or options, identifying and mitigating technical and project risks, and presenting project status to management.
• Review and update applicable product specifications and drawings for legacy products; identify acceptance criteria for product specifications.
• Partner with suppliers and internal manufacturing engineering teams to develop new processes and review current manufacturing processes, outputs, and make corrections to improve robustness.
• Activities may include process mapping, sampling, controlled design of experiments, and component inspections.
• Provide leadership on critical supplier-related programs to ensure stable supply and support overall supplier relationships.
• Manage corrective actions and implement improvements to ensure effectiveness.
• Design and implement control plans and monitor processes at internal and external manufacturing sites to ensure processes are controlled and stable.
• Utilize time management techniques (e.g., prioritization, goal setting, scheduling) to balance workload and enhance efficiency.
• Proactively manage priorities based on changing needs; adjust priorities to minimize impact on other business needs and communicate changes appropriately.

Education:

• Bachelors degree in Mechanical, Manufacturing, Materials, or Biomedical Engineering (or equivalent) required.

• Masters degree preferred.

Experience:

• Minimum of 5 years applied experience with a B.S. and 3 years with an M.S. required.
• Experience in the medical device industry strongly preferred.
• Minimum of 3 years of Project Management experience required.
• Design experience and knowledge of the full product life cycle required.

Certifications:

• PMP certification preferred.

Knowledge & Technical Expertise:

• Broad knowledge of manufacturing processes applicable to medical device manufacturing required.
• Demonstrated knowledge of relevant products and surgical techniques preferred.
• Strong knowledge in the application and selection of medical-grade materials and ability to match manufacturing processes with specific technologies strongly preferred.
• Proficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and their application in manufacturing processes strongly preferred.
• Knowledge of GD&T standards strongly preferred.
• Knowledge of GMPs, ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications related to medical devices required.
• Strong technical communication skills and ability to work independently with external suppliers required.
• Up to 10% travel required.

Leadership Skills:

• Strong business understanding and systemic view.
• Excellent analytical skills both financial and technical.
• Strong verbal and written communication skills.
• Ability to handle multiple tasks and projects simultaneously.
• Strong interpersonal relations.