Design Lead - MDR, 510(k), DHF Remediation

Job Summary

The Senior Sustaining Engineer (Productivity) role serves as a technical leader for value engineering, material optimization, supplier transitions and manufacturing efficiency improvements that improve gross margin and drive sustainable cost savings.

Key Responsibilities

Cost Reduction & Value Engineering

• Identify and evaluate cost-saving opportunities through design optimization, material substitutions, component standardization, and specification rationalization.

• Support development of business cases and prioritize opportunities based on ROI, implementation complexity, risk, and strategic impact.

• Drive value engineering initiatives while preserving product functionality, safety, quality, and customer experience.

• Partner with Procurement and Supplier Quality to identify supplier-driven cost-saving opportunities.

Design Changes & Sustaining Engineering

• Lead design changes associated with Productivity projects, including component, material, supplier, and manufacturing process modifications.

• Develop and execute design verification strategies to support product changes.

• Generate and maintain required design control documentation, including risk assessments, design outputs, test protocols, reports, and engineering justifications.

• Support regulatory submissions and product lifecycle management activities as required.

Technical Analysis & Problem Solving

• Conduct engineering analyses to evaluate design alternatives, manufacturing methods, and material options.

• Apply structured problem-solving methodologies and data-driven decision-making to identify optimization opportunities.

• Perform risk assessments and define mitigation strategies for proposed cost reduction initiatives.

• Author technical reports, engineering evaluations, and recommendation documents.

Manufacturing & Operations Collaboration

• Partner with Manufacturing, Operations, and Process Engineering teams to improve yield, reduce scrap, simplify assembly processes, and improve overall manufacturing efficiency.

• Support equipment upgrades, process improvements, and manufacturing transfers associated with cost reduction initiatives.

• Provide technical support during implementation and validation activities.

Supplier Optimization

• Support supplier transitions, dual-sourcing initiatives, and material qualifications to reduce cost.

• Collaborate with Strategic Sourcing and Supplier Quality teams to evaluate alternate suppliers and technologies.

Lead technical assessments and risk evaluations for supplier-related changes.

Skill Requirements

Technical Skills

Value Engineering / Design-to-Cost methodologies

• Product cost analysis and cost modeling

• Design Controls and Risk Management

• Root Cause Analysis and Structured Problem Solving

• Statistical Analysis and Experimental Design

• Manufacturing Processes and Process Validation

• Material Selection and Specification Optimization

• Supplier Qualification and Technical Assessment

Leadership Competencies

• Strong business acumen and financial mindset

• Ability to translate technical solutions into cost savings

• Excellent project management and prioritization skills

• Effective communication and stakeholder management

• Ability to lead cross-functional teams without direct authority

• Results-oriented with demonstrated bias for execution

• Familiarity with continuous improvement, lean, or design-to-value methodologies used to improve product cost, process efficiency, and portfolio productivity.

Travel:

• 10-25% as needed for project support

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Manufacturing Engineering, or related technical discipline.

• Minimum 5–8 years of engineering experience in a regulated manufacturing environment.

• Experience in sustaining engineering, product development, operations engineering, manufacturing engineering, or value engineering.

• Demonstrated track record of delivering measurable cost savings through engineering solutions.

• Experience supporting design controls and engineering change management processes.

Medical device industry experience preferred.

Other Requirements

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