This position is responsible for leading the technical aspects of design and development of new medical device/equipment products from initial concept stage through to release and includes evaluating designs through modeling and testing.
- Develops new technology, products, materials, processes, or equipment with minimal supervision. Independently, or as a member of a team, develops, directs, and executes plans for a major segment of complex projects.
- Compiles and analyzes operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
- Innovate, design, develop, optimize and implement processes, procedures, tooling and equipment for new products with specific emphasis on design for manufacturability.
- Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes or equipment.
- Successfully completes complex engineering work in one or more of the following: technology development, product design and development, test of materials or products, preparation of specifications, process study, research investigation (animal and clinical studies), and report preparation.
- Use fundamental PD/DFM tools to reduce variation and achieve capable processes with high production yields where required.
- Perform process optimization through DOEs, DCMs and process capability studies, as required
- Selects techniques to solve complex problems and make sound design recommendations.
- Summarizes, analyzes, and draws conclusions from complex test results.
- Designs and prepares complex reports to communicate results to technical community.
- Designs and coordinates complex engineering tests and experiments.
- Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
- Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment.
- Interfaces with Physicians/Cath Lab personnel to obtain feedback on concepts and performance of new devices.
- Translates customer needs into product requirements and design specifications.
- Responsible for engineering documentation
- Works cooperatively with quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success and identify product performance requirements.
- May train and/or provide work direction to technicians and entry-level engineers.
- Demonstrates PDP/TPD system knowledge through delivery of high quality and high impact deliverables
- Ensure adequate engineering studies, design verifications, and process validations are conducted such that well developed products are introduced into manufacturing.
- Write, execute and review validation protocols and reports where appropriate.
- Ensure documentation is completed to meet quality system requirements.
- Conduct test method development as required by project teams.
- Stay current with and ensure appropriate compliance with SOP's on all projects.
- Provide timely responses to the Corrective Action/Preventive Action (CAPA) program as required.
- Provide support as required to safety, ISO, FDA, corporate and internal audits.
- May perform other duties as assigned
- Manages in order to ensure compliance with all relevant regulatory/legal requirements
QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES
- Individual Contributor - Build Quality into all aspects of their work by maintaining compliance to all quality requirements
Type of Position
Education & Experience
- Bachelor's Level of Degree in the Engineering/Technical field of study
- 8 years of demonstrated experience in Engineering or related field
- 5 years of demonatrated experience with a Masters degree, or 3 years of experience with a PhD.
- Experience in the medical device industry preferred
- Prior experience with SolidWorks and Minitab software a plus
- Proven statistical analysis on product and process capabilities
- Proficient in the following computer software applications: MS Office - Outlook, Word, and Excel
- Exceptional interpersonal skills.
- Strong organizational skills.
- Strong communication skills (written and verbal).
- Ability to effectively communicate both internally and externally.
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.