Product Development Engineer
Location: San Antonio, TX (or remote for the right candidate)
Contract Length: 12 months (with possibility for extension)
**No C2C or sponsorship offered
The Product Development Engineer III is responsible for the management of resources to support large-scale programs and manages medium to large size projects for the Product Engineering Department. In addition, the Product Development Engineer III performs work that involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unconventional materials and difficult coordination requirements.
- Responsible for organizing, planning, monitoring, controlling and scheduling the necessary activities of medium to large scale projects to achieve goals.
- Coordinate resources between competencies (quality, engineering, research & development, manufacturing, global planning, global supply) to take the re-design of a product into production.
- Requires strong technical writing in support of design inputs, design outputs, qualification activities, regulatory requirements and related pursuits.
- Supports test methods development and execution.
- Participation in medical device design reviews as project leader, participant, and independent reviewer, as applicable
- Manufacturing and production support with outside vendors / suppliers
- Manage multiple project timelines, resources and responsibilities to achieve team, departmental, and company goals.
- Participates in the analysis of risk as part of Risk Management activities as applicable to medical devices.
- Follow Design Control procedures and comply with requirements of 21CFR820 Quality System Regulations, ISO 13485 and ISO 14971 as applicable.
- Translate user needs and other customer inputs into clear, concise design requirements and design concepts.
- Work with Manufacturing and other Product Development engineers to ensure that products are optimally designed for manufacturing.
- Prepare for and conduct various design reviews in accordance with Quality System requirements.
- Verify that designs meet functional requirements through the performance of engineering analyses and testing.
- Maintains/improves existing product designs in support of Manufacturing activities.
- Conduct and/or participate in brainstorming sessions to identify creative ideas and unique solutions
- As project lead, responsible for the coordination of Installation, Operational and Performance Qualification (IQ, OQ & PQ) activities for various equipment and manufacturing processes as part of a product re-design.
- Given projects that involve external transition of products our candidate will be responsible to chart the project and manage needed resources to complete transition successfully.
- May oversee or coordinate the work of engineers, draftsmen, technicians and other positions that assist in specific assignments when requested.
- Leads root cause investigations for the resolution of product quality problems and implements correction plans to prevent quality issues from re-occurring as part of the company CAPA process.
- Provides Design for all desirable attributes/Design for manufacturability (DFX/DFM) input and evaluation to product development.
- Supports the development and training of subordinate engineers.
- Conforms to, supports and enforces all Company policies and procedures
- Participates in any and all reasonable work activities as may be deemed suitable and assigned by management.
- Bachelor's degree in biomedical, mechanical, chemical engineering or similar engineering disciplines. Medical Device background preferred
- 5+ years of experience in a similar position with a Bachelor's OR 3 years of experience and a Master's OR no experience and a PhD in a relevant field.
- Demonstrated project management experience.
- Experience in regulated design environments a plus - specifically medical device development, Federal Drug Administration (FDA) or ISO registered.
- Ability to communicate effectively, both verbally and in writing.
- Experience with sterile medical device disposables is highly preferred.
- Experience with laminates and adhesives is desirable.
- Creative thinker and problem solver.
- Motivated and self-starter.
- Detail oriented.
- Experience in New Product Development Processes.
- Experience in Manufacturing Processes.
- Hands-on experience with design controls
- Ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude.
- Excellent understanding of fundamental mechanical principles.
- Experience with Microsoft Office Products: Excel, Word, Project
- Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.
- Attention To Detail
- Complex Problem Solving
- Corrective And Preventive Action (Capa)
- Self Motivation