The Supplier Development Engineer will provide technical leadership to Visby’s strategic partners in supply chain enabling them to meet and exceed technical sustainability of quality component supply, at scale, across Visby Medical. This includes Value Stream Mapping of the operation, establishing Engineering standards and best practices for category areas, developing and/or selecting appropriate technologies and processes, and being responsible for supplier technical evaluation, partner selection, component and technology validation, transfer, and integration, as well as identifying technical supply risks, mitigations and business impact in concert with cross-functional teams from global Operations and New Product Development sites.
- Execute in the global Technical Category strategy and associated supplier processes and management.
- Develop “should cost” models for various commodity and category strategy to enable commercial negotiations.
- Set Engineering standards and best practices for category technology. Oversee the analysis and the resolution of complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
- Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams.
- Ensure teams select, scale-up, and implement robust category processes to budget and schedule while maintaining compliance to comprehensive medical device standards.
- Ensure the appropriate implementation of design for manufacturing, design for cost, mistake proofing, and quality controls to minimize patient and regulatory compliance risks.
- Prepare business cases, supporting data, and presentation materials to facilitate strategic decision making and approval of new category technology portfolio strategies.
- Anticipate financial needs, quantifies budget to support project planning, and manages budget per forecast and schedules.
- Establish program level plans, scorecards, and performance management process es to ensure deliverables are completed in a timely and effective manner.
- Other duties as assigned.
Education and/or Experience
- Bachelor's Degree in Engineering required; Master's Degree or equivalent in Engineering, Engineering Management, Technology and/or Business Administration preferred.
- Experience in developing components and processes used in the medical device industry, as well as significant experience in managing associated technical engineering functions required.
- Professional Certification and/or State Engineering license preferred.
- Extensive experience in hands on implementation and support of medical device technologies within a highly regulated cleanroom manufacturing environment required.
- Extensive experience in Injection Molding technology development, product requirements development, and Injection Molding manufacturing processes required.
- Proven track record of successfully developing suppliers across multiple categories and commodities.
- Proven ability to evaluate manufacturing processes and automation technologies and develop a strategy for application of these systems that adds high value to the business.
- Demonstrated successful experience in a regulated industry within a manufacturing environment required.
- Demonstrated, technically sound, engineering leadership background and proven successes in designing and implementing component and processes used in the medical device industry.
- Extensive experience in strategic planning and project management.
- Excellent documentation and communication skills, interpersonal relationship skills including relationship management skills with ability to drive achievement of objectives.
- Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems.
- Strict attention to detail.
- Ability to interact professionally with integrity across all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
- Ability to work and excel within a fast paced, dynamic, and constantly changing work environment.
- Comfortable performing repetitive tasks and/or motions.
- Must be able to lift a minimum of 10 lbs.