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.