Senior R&D Engineer

Haemonetics • Boston, MA

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About The Position

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice. Job Details Position Summary The role of the Senior R&D Engineer requires an experienced leader with skills in problem-solving, stakeholder management, communication, and aligned autonomy. It is a “role-modeling” position that demands not only expertise in execution, but strategic leadership skills. This Senior R&D Engineer role is responsible for lifecycle management of commercialized apheresis and plasmapheresis medical device disposables. This role leads sustaining engineering activities including CAPA ownership, investigations, design change management, and technical support for commercial, quality and operational initiatives, while maintaining compliance with design control and regulatory requirements. This position may also act as the Product Design Owner (PDO) for assigned products, representing the product’s design history during internal audits, regulatory inspections, and notified body audits. The role partners with Quality, Regulatory, and Operations to ensure safe, compliant, and reliable products throughout their lifecycle. Specific responsibilities may include: Sustaining R&D Engineering Lead technical support and lifecycle management for commercialized Apheresis and Plasmapheresis medical device disposables Lead technical support and lifecycle management for commercialized medical device disposables Investigate and resolve design product performance issues, complaints, and manufacturing nonconformances Identify opportunities to improve product reliability, manufacturability, quality, and cost Maintain design documentation and ensure ongoing compliance with design control requirements Mentor, train, and coach junior engineers Ability to travel to internal, supplier and customer facilities CAPA Leadership Lead and support Corrective and Preventive Action (CAPA) investigations related to product design: including complaints, quality issues, and field performance Conduct root cause analysis using structured methodologies (e.g., 5 Whys, Ishikawa, Fault Tree Analysis) Define and implement Corrective and Preventive actions with cross-functional teams Ensure CAPA documentation is thorough, timely, and compliant within quality system requirements Design Change Management Lead design change activities for sustaining products, including Engineering Change Orders (ECO) Evaluate impact of design changes on: Risk management files Verification and validation requirements Regulatory submissions Manufacturing processes and suppliers Execute design verification/validation activities required to support product modifications Ensure all design changes follow formal design control and change management processes Product Design Ownership & Audit Support Serve as Product Design Owner (PDO) for assigned medical disposable products Represent the product design during internal audits, regulatory inspections, and notified body audits Present and defend design decisions using Design History File (DHF) documentation Ensure documentation readiness and traceability across the product lifecycle

Requirements

• Bachelor’s degree in Biomedical, Mechanical, Materials, Chemical or Systems Engineering or combination of relevant education and experience required
• 5+ years of engineering experience in the medical device industry.
• Demonstrated experience supporting sustaining engineering or post-launch product lifecycle management.
• Direct experience with: CAPA investigations Root cause analysis Design change implementation Design controls and DHF management
• Strong knowledge of: ISO 13485 Quality Management Systems QMSR / FDA 21 CFR 820 Design Controls ISO 14971 Risk Management Medical device design history file (DHF) maintenance Verification & validation practices for design changes

Nice To Haves

• Master’s degree in Biomedical, Mechanical, Materials, Chemical or Systems Engineering or combination of relevant education and experience preferred
• Experience working with disposable medical device technologies (e.g., injection molded components, tubing, assemblies, sterilization, packaging)
• Experience representing products during FDA or notified body audits
• Experience supporting sterilized, single-use medical devices
• Six Sigma or Lean certification

Responsibilities

• Lead technical support and lifecycle management for commercialized Apheresis and Plasmapheresis medical device disposables
• Lead technical support and lifecycle management for commercialized medical device disposables
• Investigate and resolve design product performance issues, complaints, and manufacturing nonconformances
• Identify opportunities to improve product reliability, manufacturability, quality, and cost
• Maintain design documentation and ensure ongoing compliance with design control requirements
• Mentor, train, and coach junior engineers
• Ability to travel to internal, supplier and customer facilities
• Lead and support Corrective and Preventive Action (CAPA) investigations related to product design: including complaints, quality issues, and field performance
• Conduct root cause analysis using structured methodologies (e.g., 5 Whys, Ishikawa, Fault Tree Analysis)
• Define and implement Corrective and Preventive actions with cross-functional teams
• Ensure CAPA documentation is thorough, timely, and compliant within quality system requirements
• Lead design change activities for sustaining products, including Engineering Change Orders (ECO)
• Evaluate impact of design changes on: Risk management files Verification and validation requirements Regulatory submissions Manufacturing processes and suppliers
• Execute design verification/validation activities required to support product modifications
• Ensure all design changes follow formal design control and change management processes
• Serve as Product Design Owner (PDO) for assigned medical disposable products
• Represent the product design during internal audits, regulatory inspections, and notified body audits
• Present and defend design decisions using Design History File (DHF) documentation
• Ensure documentation readiness and traceability across the product lifecycle

Benefits

• The base pay actually offered to the successful candidate will take into account, without limitation, the candidate’s location, education, job-knowledge, skills, and experience in prior relevant roles.
• Incentives may also be provided as part of Haemonetics’ employee compensation.
• For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms.
• For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms.
• Employees may also be eligible to participate in the Company’s long-term incentive plan, with eligibility and target amount dependent on the role.
• In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, “flexible time off” for salaried employees and, for hourly employees, accrual of three to five weeks’ vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits.
• Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees