Product Development Technician I

Purpose

The Product Development Technician will support the product development team. This role will assist with various activities related to product testing and validation, technical documentation, and coordination with external entities. The position involves managing multiple tasks effectively, directly contributing to the success of product development projects.

Responsibilities

· Assist in the execution of test protocols, including setup, data collection, and documentation

· Review, provide feedback, and revise technical documents. Ensure that Good Documentation Practices are followed, and that technical writing is consistent

· Assist with notetaking during meetings, ensuring effective communication and traceability of assigned action items

· Maintain cleanliness and organization of shared product development workspace

· Coordinate shipping and transportation of test samples, ensuring proper handling and documentation compliance

· Assist with selection and onboarding of new equipment, including receiving, coordination of installation and calibration, supporting validation testing and routine maintenance, and ensuring proper documentation

· Communicate with external vendors, testing facilities, and suppliers to obtain quotes, outline testing plans or sample requirements, and complete test sample submission

· Assist with organization of product development sample inventory

· Support processing technicians during human tissue processing

· Request and manage the procurement of tissue samples for research and development purposes

· Assist engineers with project-related tasks as needed

· Assist with investigation and root cause analysis, including testing and documentation

· Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures

· Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes 

· Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary

· Perform other duties as assigned

Skills

· Ability to work independently and in a team environment

· Excellent attention to detail and organization

· Excellent written and verbal communication

· Highest level of ethics and integrity

· Ability to lead and motivate the right behaviors

· Ability to multi-task and work in a fast-paced environment

· Strong technical writing

· Effective project management

· Proficiency in Microsoft Office

· Capable of prioritizing tasks and managing time effectively to meet deadlines without compromising quality

· Excellent attention to detail and the ability to follow good documentation practices

· Comfortable learning processing and handling techniques for human tissue, and ability to follow applicable safety requirements

Qualifications/Requirements

· Associates degree in a related field with 2 years of experience in lieu of bachelor’s degree

· Bachelor’s degree in related fields (Engineering, Biomedical Sciences, Biotechnology) preferred or 2 years of experience in lieu of a degree

· Experience in a laboratory, testing, or product development environment is preferred

· Experience with cleanroom manufacturing preferred

· Clearance of favorable background investigation required