Senior Design Quality Engineer

Description

Responsibilities:

• Lead and support failure investigations, root cause analysis, and problem-solving activities for non-conforming products and manufacturing processes.
• Review and approve new or modified design and process specifications, including product performance requirements, test methods, and process validation documentation.
• Contribute to and support the successful execution of quality engineering programs and project initiatives.
• Independently analyze issues and develop effective solutions to complex quality and process challenges.
• Provide guidance and direction to team members as needed.
• Partner closely with manufacturing sites to address quality concerns and drive continuous improvement.
• Serve as a quality engineering representative on cross-functional teams.
• Define and maintain product control strategies to ensure consistent product quality and compliance.
• Lead risk management activities throughout the product lifecycle.
• Ensure compliance with design control requirements and regulatory expectations.
• Plan, execute, and support process validation activities.
• Support supplier qualification efforts, including risk classification assessments and product quality evaluations.
• Assess and improve test methods used in product and process development projects.
• Evaluate customer requirements to determine applicable quality and regulatory standards.
• Review and approve the release of customer samples during product development activities.
• Conduct and participate in quality functional reviews.
• Ensure adherence to global Pharmaceutical Systems procedures, standards, and Quality Engineering practices.
• Provide support during internal audits, customer audits, and regulatory inspections, including the implementation of corrective actions.
• Drive continuous improvement initiatives focused on product quality, customer satisfaction, and market competitiveness.
• Support new customer onboarding activities, including pre-feasibility and feasibility assessments.
• Provide technical expertise, problem-solving support, and remediation guidance to manufacturing sites to prevent or minimize quality issues.
• Collaborate with customer-facing teams to address quality and product-related matters.
• Assist with supplier and internal quality system audits to evaluate the effectiveness of the Quality Management System and compliance with Good Manufacturing Practices (GMP).

Required Qualifications:

• BS degree in Engineering, or other scientific discipline and 5 years relevant experience (Medical Device/ Pharmaceutical) OR

• Masters Degree in Engineering, or other scientific discipline and 3 years relevant experience (Medical Device/ Pharmaceutical)

Knowledge and Skills:

• Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP Knowledge of design control principles.

• Good understanding of statistical methods for Quality Assurance General working knowledge of the six-sigma process methodology

• Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management. Knowledge and experience in manufacturing

• Excellent problem solving and analytical skills

• Ability to handle multiple projects simultaneously in an unsupervised environment.

• Ability to thoroughly evaluate, clearly understand and communicate all aspects of assigned project.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus
• Potential Discretionary LTI Bonus

Health and Well-being Benefits

• Medical coverage
• Health Savings Accounts
• Flexible Spending Accounts
• Dental coverage
• Vision coverage
• Hospital Care Insurance
• Critical Illness Insurance
• Accidental Injury Insurance
• Life and AD&D insurance
• Short-term disability coverage
• Long-term disability insurance
• Long-term care with life insurance

Other Well-being Resources

• Anxiety management program
• Wellness incentives
• Sleep improvement program
• Diabetes management program
• Virtual physical therapy
• Emotional/mental health support programs
• Weight management programs
• Gastrointestinal health program
• Substance use management program
• Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit

Retirement and Financial Well-being

• BD 401(k) Plan
• BD Deferred Compensation and Restoration Plan
• 529 College Savings Plan
• Financial counseling
• Baxter Credit Union (BCU)
• Daily Pay
• College financial aid and application guidance

Life Balance Programs

• Paid time off (PTO), including all required State leaves
• Educational assistance/tuition reimbursement
• MetLife Legal Plan
• Group auto and home insurance
• Pet insurance
• Commuter benefits
• Discounts on products and services
• Academic Achievement Scholarship
• Service Recognition Awards
• Employer matching donation
• Workplace accommodations

Other Life Balance Programs

• Adoption assistance
• Backup day care and eldercare
• Support for neurodivergent adults, children, and caregivers
• Caregiving assistance for elderly and special needs individuals
• Employee Assistance Program (EAP)
• Paid Parental Leave
• Support for fertility, birthing, postpartum, and age-related hormonal changes

Leave Programs

• Bereavement leaves
• Military leave
• Personal leave
• Family and Medical Leave (FML)
• Jury and Witness Duty Leave

Salary Range for Franklin Lakes, NJ: $ 110,200.00 - 176,400.00 USD Annual

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare.