Senior Engineer II, Quality Design Assurance

Integra LifeSciences; Mansfield (MA); On-site; USD 81,650 - 112,700; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) savings plan

Short- and long-term disability insurance

Job summary

A leading medical device company located in Massachusetts is seeking a Senior Engineer I, Quality Design Assurance to drive the quality development of new medical devices. The role involves collaboration with cross-functional teams, leading risk analysis, and ensuring regulatory compliance throughout product development. Ideal candidates will have engineering degrees, 5+ years of experience in regulated environments, and strong analytical skills. Competitive compensation and comprehensive benefits package included.

Qualifications

• 5 years of experience in a regulated industry.
• Excellent written and verbal communication skills.
• Ability to work independently with minimal supervision.

Responsibilities

• Lead and support design of medical devices.
• Conduct risk analysis activities.
• Develop inspection methodology for sampling plans.

Skills

Risk Management

DFSS techniques

Statistical sampling

Organizational skills

Analytical skills

Problem-solving methodologies

Education

Bachelor's degree in engineering

Tools

MS Office Suite

Statistical software

Job description

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Senior Engineer I, Quality Design Assurance

The Senior Engineer I, Quality Design Assurance, will work within the Integra Lifesciences CSS Quality organization to support the development of new Medical Devices. Working in the Design Quality team, you should excel in an environment that embraces teamwork, change, risk‑based decision making and flexibility. You should be willing to make a significant contribution to a multi‑discipline team, be self‑motivated, and have excellent written and verbal communication skills. The position will support line extensions of existing products as part of the new product development process, as well as design‑related aspects of product and process transfers between manufacturing sites. This position will have responsibility for new product introduction and development to ensure the highest levels of product quality to the end customer. You will be able to independently plan and conduct projects and/or assignments with technical responsibilities or strategic inputs with moderately detailed instructions from leaders and stakeholders.

For this Sr I role, the ideal candidate will be a Subject Matter Expert with ISO 11607, 10993, and functional cascading system requirements to component drawings, balancing the use of Y 14.5 with the needs of the business.

Responsibilities

• Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures.
• Lead and/or support risk analysis activities (FMEAs and SHAs). Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (e.g., mistake proofing, critical control points, failure mode, effects analysis).
• Apply statistical methods and process/design excellence tools to establish test plans, evaluate test data and processes.
• Use DFSS techniques, process improvement techniques, and Lean process improvement techniques.
• Proficiency in Design/Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control.
• Conduct and support the development of test methods in equipment, process, and product qualifications/validations.
• Support transfer to manufacturing activities both in product development and base business.
• Contribute to root cause investigations using various problem‑solving techniques and tools and assess effectiveness of corrective actions.
• Develop inspection methodology and acceptance criteria for inspection sampling plans.
• Provide leadership in all areas of the Quality System, including Corrective & Preventive Actions, Risk Management, Complaints, Post‑Market Surveillance, Nonconforming Materials, etc.
• Fulfill design control requirements compliant with software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines.
• Support Design and Technical Review.
• Communicate effectively at all levels within Quality, as well as cross‑functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing.
• Demonstrate project management and leadership abilities.
• Participate in internal and external audits.
• Maintain the Quality System.

Qualifications

• Bachelor’s degree in engineering (Electrical/Electronic preferred; other disciplines such as Mechanical, Systems, Chemical considered).
• 5 years of experience working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971:2019), EU MDR, MDD, IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP.
• Strong analytical skills and a working knowledge of problem‑solving methodologies.
• Working knowledge of DFSS techniques, process improvement techniques, and Lean process improvement techniques.
• 5 years of experience in a Quality Assurance role for medical device or pharmaceutical product development.
• Knowledge of industry best practices and advances in Risk Management practices, process, tools and technology.
• Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data‑driven decision making.
• Demonstrates excellent organizational, verbal and written communication skills.
• Proficient with the MS Office Suite and statistical software.
• Must be able to work independently with minimal supervision.
• Able to prioritize projects and manage assigned Design Assurance resources to meet organizational goals and objectives.

Salary & Benefits

Salary Pay Range: $81,650.00 – $112,700.00 USD. Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job‑related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation.

Employees and/or eligible dependents are eligible to participate in the following company‑sponsored employee benefit programs: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and a 401(k) savings plan.

Integra LifeSciences is an equal‑opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

Integra LifeSciences is committed to providing qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email [e-mail].