Join our client's dynamic team as the Associate Project Engineer for Private Labeling, driving the qualification and integration of specialized 3rd party products into their groundbreaking product portfolio. Collaborate closely with cross-functional teams, utilizing your expertise in design, electrical/mechanical testing, and technical writing. Be at the forefront of innovation, contributing to the expansion of their cutting-edge medical devices.

Why You Should Apply:

• Impactful Role: Spearhead the commercialization of private-labeled medical devices, taking hands-on responsibility for creation and qualification documentation.
• Collaborative Environment: Work closely with Product Management, Supply Chain, Quality, and Regulatory teams to execute qualification plans and document results.
• Versatile Responsibilities: From analyzing medical device standards to leading design reviews, experience a role with diverse challenges.
• Regulatory Expertise: Gain exposure to FDA's Quality System Regulation, ISO13485, and other regulatory requirements.
• Career Growth: Be part of an innovative company with opportunities for career advancement.

What You'll Be Doing:

• Provide project leadership for private labeling and commercialization.
• Collaborate with cross-functional teams to understand project requirements and create specifications.
• Implement customized private labeling requirements with external supplier teams.
• Analyze medical device standards and translate into purchasing specifications.

About You:

• Bachelor's degree in mechanical engineering, electrical engineering, biomedical engineering, or similar related discipline.
• Skilled in mechanical/electrical design and technical documentation.
• Structured and disciplined with strong execution focus.
• Proficient in Microsoft tools and knowledgeable in ISO13485:2016 and FDA 21 CFR QSR Part 820.