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

Pay Transparency:

The pay range for this role is:

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. 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 [email protected].

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, injectionmolded 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, componentrobustness, 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 componentperformance issues, including design change requests.
• Develop and execute verification strategies, test protocols, engineering studies, and reports to demonstrateperformance against design requirements.
• Create and maintaindesign 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 providingtechnical guidance to junior engineers and cross-functional partners.

Primary Qualifications:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a relatedtechnical discipline.

• 5+ years of product development experience in medical device, IVD, life sciences, diagnostics, or another regulated product development environment.

• Demonstratedexperience with mechanical componentdesign, plastic part design, injection molded components, high-volume disposable manufacturing, CAD, engineering drawings, verification testing, and design transfer;Proficiencywith 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.

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