Project Engineer, Private Labelling

DUTIES AND RESPONSIBILITIES:

• Provide project leadership for the commercialization of private labeled medical devices

demonstrating hands on responsibility for the creation of specifications and product

qualification documentation.

• Collaborate with Product Management Supply Chain Quality and Regulatory to understand

project requirements identify candidate products create specification requirements execute

qualification plans and document test results.

• Create plans and schedules with milestones for execution tracking.
• Work with external supplier teams to implement customized private labeling requirements.
• Analyze applicable medical device standards and translate into purchasing specifications and /

or test requirements as applicable.

• Support customer complaint investigations requiring engineering expertise.
• Support CAPA activities performing robust root cause analysis and implementation of

corrective and preventive actions.

• Complete Change Requests for initial release or updates to existing designs and

documentation.

• Lead and document design reviews.

REQUIREMENTS:

• Proficient in understanding technical drawings and specifications including mechanical and

electrical requirements and material properties.

• Skilled in the creation of technical documentation.
• Ability to read and interpret technical standards write product specifications test protocols and

reports.

• Structured and disciplined with strong focus on execution.
• Preferred - knowledgeable in the quality system requirements of ISO13485:2016 and FDA 21

CFR QSR Part 820.

• Proficient with Microsoft tools; Word Excel PowerPoint MS Project (desired).
• Excellent communication skills and ability to gain buy-in to concepts and ideas.

EDUCATION AND/OR EXPERIENCE:

• Bachelor’s degree in mechanical engineering Electrical engineering Biomedical Engineering or similar related discipline.

• 2 years engineering experience (medical Devices or similar regulated industry preferred).