Sr. Engineer, Quality Product Design

Job title: Sr. Engineer, Quality Product Design

About the Role The Sr. Engineer, Quality Product Design is responsible for ensuring the product meets the highest quality standards throughout the development and lifecycle management process. This role involves working closely with the cross-functional product engineering team to identify and mitigate risks, implement quality controls, and ensure compliance with industry regulations and standards. This role will also support continuous improvement initiatives and contribute to the development of quality assurance processes and documentation. The position is Wayne based and onsite 4 days a week.

What You'll Do

• Ensure assigned product development and/or design change initiatives are executed in accordance with Design Controls procedural requirements.
• Ensure compliance with ISO 13485, ISO 14971, FDA 21 CFR Part 820, EU MDD, EU MDR and other relevant regulations and standards.
• Ensure the safety of electromechanical software products developed by managing the product development life cycle activities to meet the quality system requirements.
• Serve as SME for the design and development process.
• Integrate with the R&D team to ensure quality and compliance in product development.
• Perform and support risk analysis and management through implementation of mitigation strategies.
• Manage risk management files throughout the product lifecycle.
• Develop and implement quality assurance plans, protocols, and standards.
• Support design verification and validation activities, including protocol development, execution, and report generation.
• Based on User Requirements provide input on design control documentation, ensuring that it meets quality and regulatory requirements.
• Ensure these components as part of Design History Files are developed, controlled, and maintained.
• Support design reviews, verification, and validation activities.
• Participate in design reviews, test method validations, cross functional teams, risk assessments, code review, and unit test inspections.
• Support Risk assessments, and associated CAPA activities.
• Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
• Also supports regulatory submissions.
• Perform periodic audits of projects against SOP’s and process.
• Prepare, support, and ensure the readiness for any potential internal and/or external audits and inspections.
• Work special projects as assigned.

What We're Looking For

• Bachelor’s degree in engineering, Computer Science, Science, or other related field.
• ASQ Certified Quality Engineer, ASQ Certified Reliability Engineer, and Six Sigma Green Belt certification is desirable.
• Minimum of 5 years of related experience that includes New Product Development and/or Sustaining Engineering.
• Strong analytical and problem-solving skills.
• Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA).
• Experience in Quality Assurance with a focus on testing, design controls, development, and/or verification & validation.
• Experience in the medical device industry or other highly regulated field (biotech, pharma, aerospace/aviation, automotive).
• Knowledgeable and demonstrated application of standards such as ISO 14971 and ISO 13485.
• Experience driving risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms.
• Project management and leadership experience is desirable.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a cross-functional team environment.
• Ability to review and understand technical standards and their requirements for products.
• Proficiency using Microsoft Office Products such as Word, Excel, or equivalent software applications.

Nice to Have

• Additional ASQ certifications and experience in design controls, verification & validation, and CAPA activities around medical devices.

Compensation & Benefits

• Salary: $115,000 - $130,000 per year.
• Bonus: 10% target annual bonus.
• Benefits: Health, Dental, and Vision insurance; 401k with company match; Paid Time Off; Wellness initiative & Health Assistance Resources; Life Insurance; Short and Long Term Disability Benefits; Health and Dependent Care Flexible Spending Accounts; Parental and Caregiver Leave; Tuition Reimbursement.