Senior Product Development Engineer -Mechanical Engineering (Hybrid Boston) (IVD and ed Dev Exp preferred)

Haemonetics Software Solutions; Boston (MA); On-site; USD 38,000 - 133,000; Full time

Benefits offered by this job

401(k) with up to 6% employer match

Employee stock purchase plan

Flexible time off

Vacation accrual (3–5 weeks)

Paid sick time

Holidays

Parental leave

Disability insurance

Tuition reimbursement

Health and welfare benefits

Job summary

Haemonetics is seeking a Senior Product Development Engineer with strong mechanical design experience to lead the development of disposable device components for an in-vitro diagnostic platform.

The role emphasizes hands-on plastic part design, CAD modeling, drawings, tolerance analysis, and design transfer for high-volume manufacturing in a regulated medical device environment.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years in medical device or regulated product development.
• Experience with CAD, design drawings, and verification testing.

Responsibilities

• Lead mechanical design of disposable device components from concept through production.
• Design plastic components for high-volume manufacturing and injection molding.
• Collaborate with suppliers, tooling vendors, and contract manufacturers.
• Own sustaining activities and lead design change requests.
• Develop verification strategies, tests, and reports to meet requirements.
• Create and maintain design control documentation and risk inputs.

Skills

Mechanical design

Injection molding

CAD

SolidWorks

Regulated medical device knowledge

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Tools

PLM systems

BOMs

Job description

Pay Transparency

Pay range for this role is $78,400.00-$133,400.00 per annum. 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.

• 401(k) with up to a 6% employer match and no vesting period
• employee stock purchase plan
• "flexible time off" for salaried employees
• 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.

If you believe you may be entitled to such information by law, you may contact 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email [e-mail].

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

Job Summary: We are seeking a Senior Product Development Engineer with strong mechanical design experience to lead the design and development of disposable device components for an in-vitro diagnostic platform. This role requires hands-on ownership of plastic part design, injection molded components, design specifications, drawings, tolerance analysis, verification planning, and design transfer for high-volume disposable manufacturing. The ideal candidate will combine strong mechanical design fundamentals with experience working directly with suppliers, tooling vendors, and contract manufacturers in a regulated medical device environment.

Key Responsibilities

• Lead mechanical design of disposable device components from concept through production, including CAD modeling, design specifications, drawings, tolerance analysis, GD&T, and verification planning.
• Design plastic components for high-volume manufacturing, with emphasis on injection molding, manufacturability, dimensional control, component robustness, cost, and scalability.
• Partner with suppliers, tooling vendors, and contract manufacturers to evaluate design tradeoffs, resolve manufacturability issues, support process validation, and transition designs into production.
• Own sustaining activities for disposable components and serve as the technical lead for manufacturing and supplier component performance issues, including design change requests.
• Develop and execute verification strategies, test protocols, engineering studies, and reports to demonstrate performance against design requirements.
• Create and maintain design control documentation, including requirements, specifications, drawings, risk documentation, design reviews, investigations, and regulatory inputs.
• Collaborate across engineering, manufacturing, quality, regulatory, procurement, and commercial teams while providing technical guidance to junior engineers and cross-functional partners.

Primary Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related technical discipline.
• 5+ years of product development experience in medical device, IVD, life sciences, diagnostics, or another regulated product development environment.
• Demonstrated experience with mechanical component design, plastic part design, injection molded components, high-volume disposable manufacturing, CAD, engineering drawings, verification testing, and design transfer; Proficiency with 3D CAD tools such as SolidWorks and experience with engineering drawings, BOMs, ECOs, and PLM or document control systems.
• Experience working with suppliers, tooling vendors, and contract manufacturers to support part qualification, manufacturing transfer, and production issue resolution.

Preferred Qualifications

• Experience with microfluidic, cartridge-based, fluidic, electromechanical, or disposable diagnostic systems.
• Familiarity with design controls, risk management, verification and validation, process validation, and regulated medical device documentation.

Skills & Competencies

Strong mechanical design judgment, clear cross-functional communication, supplier collaboration, technical problem solving, data-driven decision-making, and the ability to lead ambiguous design and manufacturing challenges.

EEO Policy Statement

Throughout our history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, our products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals. We rely on our talented global workforce to help us achieve our mission of providing innovative medical devices that advance the safety, quality, and availability of the world's blood supply. To achieve our business goals and objectives, we are committed to attracting and retaining the best and brightest talent while offering a challenging, dynamic, and exciting work environment that offers professional growth and development.