Senior Supplier Development Engineer

restor3d; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Restor3d seeks a Senior Supplier Development Engineer to qualify and validate externally manufactured components and processes, leading PPAP activities for new product introductions and vendor onboarding. You will interface with suppliers and collaborate across Product Development, Manufacturing, Operations, Supply Chain, and Quality.

Travel to supplier and internal sites (<35%) is required as you drive qualification programs, ensure process capability, and align inspection methods and

Qualifications

• Bachelor’s degree in Engineering from a four-year college is required.
• Minimum 5 years of engineering experience in regulated manufacturing.
• Minimum 3 years in supplier quality, process validation, or part qualification.
• Demonstrated experience leading PPAP or similar part qualification programs.
• Experience with MSA, Gage R&R, and IQ/OQ/PQ validations.
• Working knowledge of GD&T.

Responsibilities

• Lead PPAP activities for new product introductions as the primary supplier-facing technical interface.
• Manage schedules, deliverables and timeline risks for multiple concurrent supplier qualification projects.
• Scope, manage, and execute part and process qualification programs at supplier sites.
• Solicit and audit control plans, process flow diagrams, and risk assessments with suppliers.
• Align inspection methods and acceptance results between restor3d and suppliers.
• Specify and drive approval of CMM/vision programs and other inspection methods.
• Author and execute validation protocols and reports for supplier processes.
• Own supplier qualification onboarding and requalification triggers for changes.
• Lead root cause investigations of supplier nonconformances and corrective actions.
• Collaborate cross-functionally to set DFM and inspection requirements.
• Create quality documents to support adherence to company standards.

Skills

Minitab

Project tools

PM Certification

Education

B.S. in Engineering

Tools

SolidWorks

GMP & GDP knowledge

Job description

The Senior Supplier Development Engineer will be responsible for the qualification and validation of externally manufactured components and processes, with a focus on leading Production Part Approval Process (PPAP) activities for new product introduction and new vendor onboarding. This role is the primary technical interface to suppliers through qualification and into routine production, and a key cross department collaborator between Product Development, Manufacturing Engineering, Operations, Supply Chain, and Quality. This role will require travel to supplier and internal manufacturing sites (<35%).

Duties and responsibilities:

Principal responsibilities for the position include the following. Other duties may be assigned as necessary.

• Lead Production Part Approval Process (PPAP) activities for new product introductions, serving as the primary supplier-facing technical interface for drawing and GD&T review, measurement systems analysis, first article inspection, and production qualification.
• Manage schedules, deliverables, and timeline risks for multiple concurrent supplier qualification and product transfer projects, managing indirect cross-functional project team members without direct reporting authority.
• Scope, manage, and execute part and process qualification programs and monitor initial production runs at supplier and internal manufacturing sites.
• Solicit and audit control plans, process flow diagrams, and risk assessments with suppliers. Hold vendors to established process capability through production ramp into routine production, and investigate and resolve process degradation after qualification.
• Align inspection methods, dimensional callouts, and acceptance results between restor3d and suppliers, including measurement correlation and resolution of discrepancies.
• Specify, evaluate, and drive approval of CMM and vision programs, optical overlays, gages, and other advanced inspection methods used internally and by suppliers, qualifying inspection methods through gage studies and statistical analysis.
• Author and execute validation protocols and reports for supplier processes, establishing statistically justified sampling plans and acceptance criteria. Solicit and review supplier authored protocols and reports.
• Own technical assessment, qualification, and onboarding of suppliers, and administer requalification triggers for supplier process, tooling, material, or facility changes, and supplier change notifications including end-of-life components.
• Lead root cause investigation of supplier nonconformances, drive supplier corrective action through closure, and support incoming inspection strategy and sampling.
• Collaborate cross-functionally to set DFM and inspection requirements, and be the technical liaison to suppliers for qualification status, risk, and schedule.
• Create quality documents to support adherence to company quality standards.
• Position may involve indirect management of project team members but has no direct reports.

Required Skills:

• Minitab or equivalent statistical software
• Smartsheet, MS Project, or similar project tools required.
• PMP, Six Sigma, Lean, ASQ CQE, or ASME GDTP certification preferred.

Education and Experience:

• Bachelor’s degree (B.S.) in Engineering from a four-year college in an engineering discipline (Mechanical, Materials Science, Industrial, etc.) is required.
• Minimum 5 years of engineering experience in regulated manufacturing required.
• Minimum 3 years in supplier quality, process validation, or part qualification required.
• Demonstrated experience leading PPAP or similar part qualification programs required.
• Experience in MSA, Gage R&R, and IQ OQ PQ validations required.
• Experience with GD&T required.
• Experience managing suppliers and corrective action
• Demonstrated project management, leadership, and cross department skills required.
• Working knowledge of additive manufacturing, machining, and inspection preferred.
• Working knowledge of SolidWorks, GMP, and GDP is preferred.
• Working knowledge of design control and risk management preferred
• Experience in FDA 21 CFR 820, ISO 13485 Quality system is preferred.

Physical Requirements:

• Position may involve the use of basic hand tools, dimensional inspection equipment, coordinate measuring machines and optical comparators, additive manufacturing and machining equipment, and eye and hearing protection.
• Position may involve exposure to additive manufacturing powders, resins, solvents, and machining debris at restor3d and supplier sites.