Jobs in the United States

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Added 1 min ago
Principal Embedded Software Engineer
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Lead the software engineering team for complex embedded control systems, considering safety, performance, and security requirements
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…high retention rate is influenced by a unique compensation program for positions that are more than just jobs - they're chances to grow, do what you love and build a career with…
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Lead Generator Project Engineer-2
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…management, technical direction, and drives coordination of engineering activities and critical issue resolution for OTR-related issues for all assigned Generator projects. The Lead…
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Senior Planner, Program Management Office
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Added 5 mins ago
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Added 8 mins ago
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Medical Campaign Analytics Manager
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Added 11 mins ago
Buyer
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…partnering with suppliers and internal stakeholders, including Engineering, Quality, Customer Service, and Program…
Added 12 mins ago
Product Manager
Company 19 - John Hancock Life Insurance Company (U.S.A.)
Remote, United States
…journeys, servicing, and operational workflows. The Product Manager plays a key role in turning business strategy and customer needs into valuable software…
Added 12 mins ago
Modality Manager, CT
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Closed listing

CONMED

Design Quality Engineer

Denver, CO, United States

$74,200 to $92,000 USD / year

This opening has closed.

The original listing is kept below for reference.

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About employer

Job details

Pay: $74,200 to $92,000 USD / year
Posting language: English
Posted: Nov 10, 2026

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Original job description

Archived listing. The details below describe a past opening.

The Design Quality Engineer is responsible for supporting all quality engineering activities to support the new product life cycle, from concept to commercialization, and sustaining activities. The Design Quality Engineer will serve as the quality engineering contact and be a key member of the cross-functional development and sustaining teams. The Design Quality Engineer serves as the key resource for ensuring compliance to ISO, EU MDR, and FDA QSR requirements for Medical Devices. The Design Quality Engineer takes the lead with quality initiatives with inter-organizational impact following QSR, CONMED Policies, standards and regulations. Works under direction from Quality Management.

Key Duties and Responsibilities

Supports and provides direction to product development teams for the required quality deliverables.
Ensures that product design meets customer expectations, regulatory requirements, appropriate voluntary standards, and all corporate requirements. Shows focus toward continuous improvement.
Review, assess, and approve product design documentation to ensure compliance throughout product development cycle. Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
Troubleshoot and direct the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships.
A relentless focus on the safety and the efficacy of the medical device.
Review and approve engineering designs/changes for adequate quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
Review and approve design verification and design validation protocols and reports. Ensure design activities prove design inputs and user needs are adequately addressed.
Leads and provides support on risk management activities with a focus on clinician and patient safety.
Support product development through capability assessment, analyzing performance data, facilitating problem-solving activities, developing quality tools, and quality techniques.
Support sustaining activities such as complaint investigation and complaint trending. Monitor and analyze manufacturing and service trends. Perform Predicate Device reviews and surveillance reports. Able to perform data mining, analyze data and create trend reports.
Demonstrate quality assertiveness and be able to represent the Quality function in various roles such as product support and lifecycle management.
Investigates process and product issues identified through complaints and trend analysis of other conformance data. Works with other functional groups to resolve difficult quality problems on products, processes, or materials used in manufacturing operations.
Direct and facilitate investigations and the corresponding preventative actions and corrective actions that result from abnormal results, customer complaints, quality inquiries, and other quality performance indicators.
Travel Requirements (including international): 0-5%
Support internal and external audits. Provide support for audit preparation activities. Participate in the back-room as needed.

In addition to the main responsibilities listed above the manager is allowed to USE discretion TO add further duties and tasks based on the business needs which are not explicitly listed here.

MINIMUM REQUIREMENTS

B.S. degree in Engineering such as Electrical, Mechanical, or Biomedical Engineering and 2+ years of medical device experience (or equivalent work experience), or M.S. and 1+ years of medical device experience.

PREFERRED REQUIREMENTS

Must be able to interpret and apply Quality Systems Regulations and ISO quality requirements and stay abreast of new industry standards and concepts.
Knowledge of design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.Involvement in back-room support process during external audits and/or inspections.
Experience reviewing design verification and design validation protocols.
Excellent communication, problem solving, organizational, and interpersonal skills are required.
Must be capable to plan schedules and to manage multiple projects simultaneously.
Strong technical writing skills.
Works independently with minimal direction or supervision.
Decision intelligence.

Physical Requirements

Ability to sit/stand for 8 hours.
Ability to sit at a computer terminal for an extended period.

ADA Disclosure:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This position is not eligible for employer based sponsorship.

Disclosure as required by applicable law, the annual salary range for this position is $74,200 - $92,000. The actual compensation may vary based on geographic location, work experience, education and skill level. The salary range is CONMED’s good faith belief at the time of this posting.

Colorado residents: In any materials you submit, you may redact or remove age identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Benefits:

CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.

Competitive compensation
Excellent healthcare including medical, dental, vision and prescription coverage
Short & long term disability plus life insurance -- cost paid fully by CONMED
Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
Employee Stock Purchase Plan -- allows stock purchases at discounted price
Tuition assistance for undergraduate and graduate level courses

Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!

CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.

About employer

More about this job

Skills

Product life-cycle
Process improvement
Documentation
Regulatory compliance
Approve engineering design
Risk management
Reporting
Troubleshoot
Problem solving
Perform data mining
Biomedical engineering
Quality control systems
Inspection
Communication skills
Interpersonal skills
Plan schedule
Technical writing

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Jobs in the United States