Product Development Engineer

Position Summary

We are seeking a Product Development Engineer I/II to join our growing team. This role is responsible for driving product development activities from concept generation through market launch, ensuring alignment with user needs, regulatory standards, and business objectives. The ideal candidate will be detail-oriented, technically strong, and thrive in a dynamic, cross-functional environment.

Key Responsibilities

• Support the full product development lifecycle, from early concept through commercialization.
• Generate and maintain design history documentation in compliance with regulatory and industry standards.
• Translate user needs into engineering requirements and plan/execute verification and validation testing.
• Apply statistical methods to determine appropriate sample sizes and ensure robust study design.
• Develop and implement research approaches and design of experiments (DOE) tailored to project objectives.
• Plan and execute engineering runs (PPQs), including writing validation protocols, drafting test instructions, executing trials, and analyzing data.
• Define and document product and process requirements, specifications, and tolerances.
• Lead and manage projects, ensuring timelines, deliverables, and budgets are met.
• Create and review technical documentation with strong attention to clarity and compliance.
• Independently lead cross-functional meetings, driving alignment and decision-making across departments.
• Maintain compliance with 21 CFR 1271 regulations and AATB guidelines (preferred).
• Ensure adherence to ISO 5 cleanroom and aseptic techniques, particularly in tissue banking environments (preferred).
• Adapt effectively in a fast-paced, dynamic setting with evolving project priorities.

Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, or related field (advanced degree preferred).
• 2 years of experience in product development, preferably in medical devices, life sciences, or biotech.
• Strong knowledge of product development and commercialization processes.
• Proven project management skills with the ability to manage multiple priorities.
• Demonstrated expertise in technical writing and documentation.
• Strong communication and leadership skills with the ability to influence and align cross-functional teams.
• Familiarity with tissue banking, aseptic techniques, and ISO cleanroom operations strongly preferred.
• Knowledge of FDA regulations (21 CFR 1271) and AATB guidelines preferred.