Design Quality Engineer

FHLB Des Moines; Greenwood Village (CO); On-site; USD 74,000 - 95,000; Full time

Job summary

CONMED is seeking a Design Quality Engineer to support quality activities across the medical device lifecycle, from concept to commercialization and sustaining. You will be the quality engineering contact on cross‑functional teams to ensure compliance with QSR, ISO 13485, EU MDR, and related standards.

The role emphasizes risk management, design verification and validation, and CAPA leadership, with collaboration across manufacturing and suppliers to ensure product safety, reliability, and

Qualifications

• B.S. in Electrical, Mechanical or Biomedical Engineering with 2+ years medical device experience (or M.S. with 1+ year).
• 1 year experience interpreting and applying Quality Systems Regulations and ISO quality requirements OR 1 year in design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.
• Professional certifications (CQE, CQA, CMQ/OE, Lead Auditor) desirable.
• Design for Six Sigma training and knowledge of statistical methodologies.

Responsibilities

• Supports and provides direction to product development teams for the required quality deliverables.
• Review, assess, and approve product design documentation for compliance throughout product development cycle.
• Review and approve engineering designs/changes for quality, reliability, maintainability, risk management, modeling, systems design, assessment tools, reporting, and manufacturability.
• Lead risk management activities with a focus on clinician and patient safety.
• Support sustaining activities such as complaint investigation and complaint trending.
• Monitor and analyze manufacturing and service trends; perform predicate device reviews and surveillance reports.
• Travel requirements (including international): 0-5%.
• Support internal and external audits and audit preparation activities.

Skills

Communication

Problem solving

Organizational skills

Interpersonal skills

Technical writing

Planning & project management

Independent work

Decision intelligence

Education

B.S. in Electrical/Mechanical/Biomedical Engineering

M.S. in Engineering

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 ResponsibilitiesSupports 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 REQUIREMENTSEducation and ExperienceB.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.1 year of experience in interpreting and applying Quality Systems Regulations and ISO quality requirements OR 1 year of experience in design controls, 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and applicable medical device regulations.PREFERRED REQUIREMENTSProfessional certifications (CQE, CQA, CMQ/OE, Lead Auditor) are desirable.Design for Six Sigma training is desired along with knowledge of statistical methodologies.Involvement in back-room support process during external audits and/or inspections.Experience reviewing design verification and design validation protocols.Other AttributesExcellent 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 RequirementsAbility to sit/stand for 8 hours.Ability to sit at a computer terminal for an extended period.N/ADisclosure as required by applicable law, the annual salary range for this position is $74,200 to $94,600. 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.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.*****No visa sponsorship will be provided. Relocation assistance will be considered*****Benefits:CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.Competitive compensationExcellent healthcare including medical, dental, vision and prescription coverageShort & long term disability plus life insurance - cost paid fully by CONMEDRetirement Savings Plan (401K) - CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay periodEmployee Stock Purchase Plan - allows stock purchases at discounted priceTuition assistance for undergraduate and graduate level coursesKnow 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.