Sr. Staff Engineer - Process & Equipment Design

We are a global medical technology company advancing the world of health through transformative solutions. This role bridges Product Development and Manufacturing, translating new product introductions and design changes into scalable, compliant, and operator-focused manufacturing solutions.

About the role

This position leads the development, deployment, and industrialization of manufacturing equipment and process technologies for the Specimen Management Business Unit. Success is measured through on-time project execution, improved Overall Equipment Effectiveness (OEE), reduced Cost of Goods Sold (COGS), and adherence to regulatory and quality requirements.

Responsibilities

• Develop and execute equipment and process technology roadmaps aligned with business and site priorities.
• Define User Requirements Specifications (URS) and equipment specifications to support manufacturing, safety, quality, and regulatory requirements.
• Partner with the PMO to ensure projects remain on schedule, within budget, and aligned with approved scope.
• Support long-term capital planning and equipment investment strategies.
• Lead multiple capital equipment projects from concept through design, FAT/SAT, installation, validation, and production launch.
• Manage project portfolios to ensure successful execution and prioritization of resources.
• Select, manage, and oversee suppliers and equipment vendors, including contract negotiations and performance management.
• Drive risk management activities through FMEA, design reviews, and validation planning and execution.
• Ensure compliance with stage-gate governance processes and project management standards.
• Partner with Product Design teams to incorporate Design for Manufacturability (DFM) principles early in the product development process.
• Collaborate with Quality and Regulatory teams to ensure compliance with GMP, ISO, FDA, and other applicable regulations.
• Work closely with Operations and Maintenance teams to optimize equipment reliability, maintainability, and operator safety.
• Build strong partnerships across internal teams and external suppliers to support successful equipment deployment.
• Oversee equipment integration, commissioning, and process optimization during production ramp-up.
• Drive standardization of equipment, processes, and best practices across manufacturing sites.
• Lead structured problem-solving efforts to address production challenges and improve process performance.
• Identify and implement opportunities to improve productivity, quality, efficiency, and cost.
• Support continuous improvement initiatives utilizing Lean, SPC, and other operational excellence methodologies.

Requirements

• B.S. in Engineering.
• 10 years of engineering and process development experience within a regulated manufacturing environment.
• Medical device industry experience.
• Up to 25% domestic/international travel for site integration and supplier FAT/SAT.

Preferred Qualifications

• Bachelor’s in Mechanical, Electrical, or related Engineering.
• MBA or MS in Engineering.
• Proven leadership experience managing engineering teams, with direct people management experience.

Skills

• Proven ability to manage capital projects, influence cross-functional teams, and deliver results in regulated environments.
• Experience with stage-gate governance, risk analysis (FMEA), and validation.
• Strong financial acumen and project management skills.
• Familiarity with Lean, SPC, and continuous improvement methodologies.

Schedule

Minimum of 4 days of in-office presence per week at the Franklin Lakes, NJ location.

Pay

Salary range: $168,600 - $269,800 USD annually for Franklin Lakes, NJ.

This role includes annual bonus potential and discretionary long-term incentive (LTI) bonus.

Benefits

• 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
  • 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