HCLTech
Polyguard
← All roles

Engineering & R&D

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

Others, United States

Verified applicants only — secured by Polyguard

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

null

Apply for this role

Complete the form below. When you submit, you’ll be asked to complete a quick Polyguard Trust Check on your phone, and your application is only sent once verification passes.

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at our company are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305
OMB Control Number 1250-0005

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

Because we do business with the government, we must reach out to, hire, and provide equal opportunity to qualified people with disabilities. To help us measure how well we are doing, we are asking you to tell us if you have a disability or if you ever had a disability.

Completing this form is voluntary, but we hope that you will choose to fill it out. If you are applying for a job, any answer you give will be kept private and will not be used against you in any way.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Blindness
  • Deafness
  • Autism
  • Cancer
  • Diabetes
  • Epilepsy
  • HIV/AIDS
  • Schizophrenia
  • Muscular dystrophy
  • Cerebral palsy
  • Multiple sclerosis (MS)
  • Major depression
  • Bipolar disorder
  • Post-traumatic stress disorder (PTSD)
  • Obsessive compulsive disorder
  • Intellectual disability (previously called mental retardation)
  • Missing limbs or partially missing limbs
  • Impairments requiring the use of a wheelchair

Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

Protected by Polyguard.