Design Quality Engineer

CONMED Corporation; Denver (CO); On-site; USD 74,000 - 92,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare coverage

Disability and life insurance

401K with company match

Employee Stock Purchase Plan

Tuition assistance

Job summary

CONMED Corporation is seeking a Design Quality Engineer to support the full product lifecycle from concept through commercialization and sustaining activities. The role ensures compliance with ISO, EU MDR, and FDA QSR requirements for medical devices and leads quality initiatives with cross-functional teams.

You will review designs, support risk management, and drive investigations and corrective actions while advocating patient safety and product reliability.

Qualifications

• Requires B.S. in Engineering and 2+ years medical device experience (M.S. with 1+ years acceptable).
• Familiar with Quality Systems Regulations, ISO 13485, ISO 14971, EU MDR, and FDA QSR.

Responsibilities

• Support product development teams with required quality deliverables and ensure design meets requirements.
• Review and approve design documentation, verification and validation protocols and reports for quality and compliance.
• Lead risk management activities focusing on clinician and patient safety.
• Investigate quality issues, drive corrective actions, and lead data-driven problem solving across functions.
• Support internal/external audits and supplier quality activities.

Skills

Quality engineering

Regulatory knowledge

Cross-functional teamwork

Risk management

Problem solving

Communication

Education

B.S. in Engineering (Electrical/Mechanical/Biomedical) + 2+ yrs medical device exp

Job description

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

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.