Senior Supplier Development Engineer
Engineers with 5 years + experience looking for the next step in their career will also be considered!
This position will support key strategic projects intended to transfer product/processes, develop, validate, and launch production on various supplier sites within the region.
- Working with multiple internal project teams, coordinate and execute supplier development deliverables with various external extrusion, molding, catheter sub-assembly, and packaging materials.
- Assist suppliers to ensure that selection, development, and validation of manufacturing processes, equipment, and tooling are performed to the meet procedures, ISO 13485 and FDA requirements.
- Primary contact for designated suppliers and ensures that all phases of product/process development conforms to required quality standards, meets program timing/key milestones and are ready for production launch.
- Develop and write technical reports, summaries, and validation/verification documents. Properly documents activities in accordance with best engineering practices, company procedures, and regulatory requirements.
- Resolve supplier component-related problems, including yield issues and failure analyses. Evaluates and recommends corrective actions to improve process yields. Assist in providing guidance and direction with corrective actions for designated suppliers.
- Provide ongoing quality monitoring and interface with external suppliers on line issues to ensure highest quality product is maintained.
- Trains and educates suppliers on industry best practices and requirements to develop and improve their ability to meet medical device manufacturing industry expectations.
- Identify and ensure implementation of opportunities to optimize and improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to internal and external standards.Facilitates and manages product level design verification testing that leads to the approval of components for use in our products.
- Support tasks/assignments/projects as necessary.
- Work with internal groups such as Program Management, Manufacturing Engineering, Design Engineering, Supplier Quality Engineering, and Regulatory Affairs to execute various non-supplier development project deliverables.
- Performs other duties and responsibilities, as assigned.
Required Education & Skills:
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Industrial/Manufacturing Engineering or related field with a minimum of 5 years experience in medical device or other high-reliability/highly-regulated manufacturing, or equivalent education, experience, skill set, and/or proven performance.
- Medical device manufacturing experience, including ISO13485 and FDA requirements is required.
Strict attention to detail.
- Well-developed understanding and with experience in performing medical device manufacturing process validations (IQ/OQ/PQ).
- Equipment knowledge and process experience for injection molding, adhesive bonding, metals processing, and/or product assembly or high-volume automation.
- Experience with statistical techniques such as Gage R&R, SPC, Process Capability Analysis, and ANOVA methods.
- Good engineering judgement and demonstrated analytical, quality problem analysis, and resolution skills using Six Sigma methodologies.
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
- Strategic planning and critical thinking skills to be able to plan, organize, and manage multiple priorities.
- Demonstrated ability to establish and sustain relationships with external suppliers or vendors.
Ability to manage competing priorities in a fast paced environment.
- Strong technical writing skills in developing engineering protocol and report documentation.
Ability to read and interpret engineering drawings for the purpose of understanding equipment function and product design.
- Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
- Familiar with Just-in-Time and Lean Manufacturing techniques.
- Strong written, presentation, and communications skills.