Engineer II, Product Development

Position Summary

The Engineer II is responsible for supporting and executing product development activities for medical devices in accordance with applicable regulatory requirements and the company’s quality management system. This role has a strong focus on design controls, risk management, product verification and validation, design transfer, and 510(k) regulatory requirements. This position works cross-functionally with Quality, Regulatory Affairs, Operations, Manufacturing, Clinical, and other stakeholders to ensure products are developed, documented, evaluated, and transferred to manufacturing in compliance with applicable requirements. The Engineer II will also support Quality by Design (QbD) activities related to products and processes in biologics development, process optimization, process controls, and risk management.

Essential Duties & Responsibilities

• Execute and maintain product development activities in accordance with the company’s design controls procedure and applicable regulatory requirements (FDA 21 CFR Part 11, Part 820, ISO 13485, and ISO 14971 requirements).
• Develop and maintain design and development documentation, including but not limited to user requirements, design inputs and outputs, product specifications, design verification and validation documentation, design reviews, design transfer documentation, design changes and change control records.
• Ensure design inputs are clearly defined, traceable, testable, and appropriately linked to design outputs and verification/validation activities.
• Coordinate cross functional product development activities and resolve technical issues affecting project timelines or product requirements.
• Support design transfer activities to ensure the final product and associated documentation are suitable for GMP manufacturing.
• Apply QbD principles to product and process development for biologics, ensuring systematic identification of critical quality attributes (CQAs), critical process parameters (CPPs), and risk mitigation strategies.
• Support and/or lead product risk management activities in accordance with ISO 14971 and company procedures.
• Develop, review and maintain risk management documentation, including, but not limited to Preliminary Hazards Analysis (PHA), Design/Usability FMEA (d/uFMEA), risk control measures, residual risk evaluation, risk benefit analysis, risk management reports.
• Evaluate the impact of design or manufacturing changes, supplier changes, and new intended uses on product risks.
• Ensure appropriate testing and documentation are identified before implementation of product changes.
• Participate in assessments of new hazards, failure modes, complaints, adverse events, and post market information to determine potential impacts to the risk management file.
• Support product development activities associated with FDA 510(k) submissions, including Traditional, Special, and applicable regulatory pathways.
• Assist with preparation of responses to FDA questions and request for additional information.
• Apply statistical tools for data analysis, product or process characterization, and design of experiments (DOE) to interpret experimental data, establish product and process understanding and support risk-based decision making.
• Develop and execute laboratory studies, feasibility testing, and process development experiments.
• Develop, optimize and scientifically evaluate analytical methods to support product characterization, product development and process evaluation.
• Participate in investigations related to nonconformances, complaints, CAPAs, and other quality events when related to product design or performance.
• Support validation activities associated with manufacturing processes, equipment and test methods, when applicable.
• Support continuous improvement initiatives related to product design, development processes, and engineering documentation.
• Mentor entry-level engineers or interns as needed.
• Perform other duties and projects as assigned.

Skills & Abilities

• Strong understanding of medical device design controls and product development processes (e.g., FDA 21 CFR Part 820, Part 210/211, Part 1270/1271, ISO 13485, ICH).
• Knowledge of FDA 510(k) requirements and substantial equivalent concepts.
• Understanding of verification and validation principles.
• Strong technical writing, documentation, analytical, and problem solving skills.
• Proficiency with statistical analysis and DOE (Minitab, SPSS or similar).
• Ability to manage multiple tasks and meet deadlines in a fast-paced environment.
• Excellent written and verbal communication skills.

Education & Experience

• Bachelor’s degree in biomedical, biotechnology, chemical or related engineering field (Master’s preferred).
• Experience working within a regulated Quality Management System.
• Experience in medical device product development.
• Experience supporting one or more FDA 510(k) submissions.
• Experience with design controls system and DDF management.
• Experience applying ISO 14971 risk management.
• 2-4 years of relevant experience in the medical device, biotechnology, or pharmaceutical sector.

Preferred Experience

• Experience with product and process development leveraging a QbD approach related to Biologics.
• Knowledge of biocompatibility, sterilization methods, and packaging validation.
• Understanding of project management principles.

Physical Requirements

Ability to work in laboratory, office, and cleanroom environments. Some travel may be required (<10%).