Design Lead - MDR, 510(k), DHF Remediation
United States
Job Description
Design Lead - MDR, 510(k), DHF Remediation
| Others, Rhode IslandOthers, Illinois

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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Maximum Salary (US):  128000
Minimum Salary (US):  69000
Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 227,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending March 2026 totaled $14.7 billion. 

 

Compensation and Benefits

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.