The Senior Sustaining Engineer is responsible for the management of resources to support large-scale programs and manages medium to large size projects for the Sustaining Engineering Department. In addition, the Senior Sustaining Engineer 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.
Duties and Responsibilities:
- 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.
- Requires a minimum of 6 years of experience in a similar position
- Bachelor Degree in Biomedical, Mechanical, Chemical Engineering or similar Engineering disciplines
- 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.