Design Quality Engineer II

FHLB Des Moines; Memphis (TN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation

Excellent healthcare including medical

401K with company match

Tuition assistance

Employee referral program incentives

Job summary

CONMED Corporation seeks a Design Quality Engineer II to support quality engineering activities across the new product life cycle, from concept to commercialization, and sustaining activities. The role serves as the quality engineering contact and key resource for ISO, EU MDR, and FDA QSR compliance in a cross-functional team.

The on-site position in Memphis, TN requires collaborating with multiple functions to ensure product design meets customer, regulatory, and standards requirements while

Qualifications

• Requires a B.S. in Engineering and 2+ years medical device experience (or an M.S. with 1+ year).
• Familiarity with Quality Systems Regulations and ISO quality requirements; knowledge of 21 CFR 820, ISO 13485, ISO 14971, EU MDR.
• Professional certifications (CQE, CQA, CMQ/OE) are desirable.
• Design controls knowledge and ability to apply risk management.

Responsibilities

• Support product development with required quality deliverables across the life cycle.
• Review and approve design documentation to ensure regulatory compliance.
• Lead risk management activities focusing on clinician and patient safety.
• Investigate quality issues and drive corrective actions across functions.
• Support internal and external audits and surveillance activities.

Skills

Quality engineering

Regulatory compliance

Risk management

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

CQE

CQA

CMQ/OE

Job description

The Design Quality Engineer II 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. This is an on‑site role in Memphis, TN.

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 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.

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. Must be capable to plan schedules and to manage multiple projects simultaneously. Professional 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. Excellent communication, problem solving, organizational, and interpersonal skills are required. 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.

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!

A 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.

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. CONMED Corporation is a progressive, global medical device company. Through thoughtful leadership, innovation and team work, we are changing the future of medicine. Our 3,500 employees worldwide make meaningful contributions, positively impact the business, and advance in their careers as our company and product portfolio grows. We are a leader in Orthopedics, General Surgery, Gynecology, Gastroenterology, Pulmonology, and Anesthesiology and our employees enjoy challenging and diverse job opportunities across these varied specializations. We are headquartered in upstate New York with additional domestic facilities in FL, CA, MA, CO, and GA. We have an international presence in more than 20 locations throughout Europe, Australia, Latin America, Asia, North America, and the Middle East.