Experience:
3 to 8 years of experience as a product design/development engineer in the medical device or pharmaceutical industries. Experience with designing for high-volume manufacturing methods such as molding and stamping, and automated assembly and packaging processes. Experience with designing metal and plastic components. Demonstrated experience with all phases of the Design Control process: implementing product changes through a structured, phase-gated, product development process. Demonstrated understanding of product development considerations for tightly controlled, high-volume manufacturing processes. Clear understanding of manufacturing process validation including FAI/FAT, development and IQ/OQ/PQ. Proficiency with Pro-E or SolidWorks. Strong technical skills and judgment. Good communication skills. Team orientation with strong interpersonal and influence skills. Strong motivational fit. Familiarity with project planning skills and leadership methods. Understanding of disciplined product development processes, regulatory, and quality requirements.
Responsibilities:
This position is within the R&D organization of Client Medical. This position will contribute to design and development activities focused on identifying, developing, and implementing solutions to support the current and future product portfolio. More specifically, the job responsibilities will include:
- Support design and development activities for products within the product portfolio.
- Support products in terms of design, quality, manufacturing, supply continuity, and cost improvement.
- Participate in executing technical and/or cross-functional project work.
- Contribute to innovation by proactively generating Client concepts to improve current product performance or enhance products' ability to address customer needs.
- Provide solid technical skill and be responsible for solving technical problems.
- Develop creative and Client solutions to technical problems.
- Perform and plan assigned product development activities.
- Set priorities for self and contribute to team planning.
- Ensure compliance with Client quality policies, procedures, and practices through appropriate communication, training, and education of sound quality assurance principles.
- Ensure compliance with all local, state, federal, and Client safety regulations, policies, and procedures.
- Accountable for the success of assigned tasks and project deliverables.
- Participate in and lead periodic design reviews of projects.
- Ensure appropriate processes are followed for effective and timely engagement of related parties in completion of designated project activities.
- Develop understanding of customer needs and processes to ensure relevant and innovative product development solutions.
- Develop and demonstrate interpersonal influence and persuasion skills.
- Promote and leverage diversity to achieve best outcomes.
- Ensure all interested parties have opportunities to influence and contribute to decisions and outcomes.
- Demonstrate agility and action orientation when facing change and uncertainty.
Qualifications
B.S. Mechanical Engineer, Bachelor's Degree
Additional Information
- 3-D CAD Modeling
- Ability to work individually and with the team on multiple projects simultaneously.