- Leads implantable medical device new product development programs with a focus on project management, design control, and design/process validation deliverables.
- Designs and develops medical textile based structures covering weaving, knitting, braiding, and non-woven textile applications and value added processes.
- Demonstrates a high degree of intrapersonal skill with ability to fosters key customer relationships and participate on high performing teams.
- Develops products based on customer needs and specifications.
- Researches and implements new technologies/capabilities required to meet customer’s needs.
Principal Duties and Responsibilities:
Lead and function as a contributing member of multidisciplinary project teams in the design, development, and manufacturing of medical device components:
- Develop and execute design and process validation activities including IQ, OQ and PQ protocols, testing and reports.
- Prepare project management deliverables including timelines with milestones.
- Create risk management and design control documents – per ISO 13485 including process flow charts, PFMEA, and control plans.
- Support project teams on selecting materials, appropriate manufacturing techniques, and developing textile components and related value added capabilities for medical device design.
- Interact with customers, medical device engineers to understand the unmet needs and offer solutions.
- Interact with outside vendors, suppliers, and consultants.
Education and/or Experience:
- BS or MS in Mechanical Engineering, Biomedical Engineering, Textile Engineering or equivalent.
- Minimum of 3-6 years of experience with implantable medical device new product development in compliance with QSR and ISO 13485 requirements.
- Must be capable of handling multiple projects/tasks at the same time.
- Knowledge of Design/Process Excellence (Six Sigma black belt certified is a plus).
- Experience working with bio-absorbable polymer based implantable medical devices.
- Experience in the cardiovascular and/or orthopedic implantable medical device industry.
- Direct experience with Knitting, Weaving, Braiding or Non-woven product development, fine denier constructions..
Other Skills and Abilities:
- Good interpersonal relationship and people skills. Strong team player.
- Potential to lead project team.
- Ability to incorporate manufacturability into the new product development.
- Excellent verbal and written communication skill.
- Have passion and enthusiasm for innovation.
- Proven problem solving skills.
- Good understanding of statistical tools and DOE
- Comfortable with all applications of MS Office