Manufacturing Engineer

SUMMARY OF POSITION: Responsible for meeting internal and external customer manufacturing requirements for the new product launch of surgical instruments and implants through robust process design. The position will participate in a customer focused team facilitating all activities associated with a product launch between the customer, supply chain, and company.

ESSENTIAL FUNCTIONS:

• Supports project requirement checklists through justification and/or rationalization of activities associated with product launch.


• Supports project planning and timeline execution.


• Supports Design for Manufacturability (DFM) with the Client, shared with Program Manager.


• Supports Device Master Record (DMR) development, shared with Program Manager.


• Responsible for the process flow development including value stream mapping, process and product characteristics, and CTQ flow through.


• Supports pFEMA development and team discussions along with managing the risk mitigation activities and testing, shared with Quality Engineer.


• Supports Control Plan (CP) development including inspection methodology, prevention controls, detection controls, reaction plans, inspection frequency rationale, and ongoing monitoring.


• Leads engineering test protocol development and reporting for process characterization and process testing.


• Supports supply chain development.


• Supports post production meetings.


• Assists in project tracking and metric development to monitor ongoing performance.


• May represent company in meetings with Client to negotiate product design and process deliverables.


• Creates operator work instructions to communicate process knowledge.


• Works proactively with the team to share best-practices, and lessons learned.


• Fosters close and productive relationships with cross-functional counterparts.


• Understands project schedules for all projects that are within the department.

EXPERIENCE / EDUCATION:

• Bachelors Degree in Mechanical Engineering highly preferred or the equivalent years of work experience.


• Additional training or certification in lean process and product development is ideal.


• Minimum three years of experience or educational background, with tight tolerance methods in machining and measurement system applications, blueprint reading, GD&T, working knowledge of short run process control methods, statistical analysis, DOE, ISO standards and FDA quality system regulations.


• Minimum three years previous experience in similar role is preferred.


• Windows-based computer knowledge required.


• Knowledge of Design for Manufacturability (DFM) principles, biocompatibility requirements for materials, ISO13485 and US QSR 21 CFR, Part 820 Medical Devices, and basic understanding of the human anatomy preferred.


• Knowledge of various metal and polymer materials as well as testing specifications preferred.

SKILLS:

• Excellent interpersonal and communication skills.


• Individual is able to work with minimal supervision and actively participate in a team oriented, continuous improvement, manufacturing environment.


• Superior organizational skills and attention to detail required.


• Strong leadership, ability to handle multiple tasks and prioritize in a fast-paced environment.


• Strong problem-solving, decision-making, and process improvement skills. Windows-based computer knowledge required and working experience with CAD / CAM systems preferred.