What are the responsibilities and job description for the Project Engineer, Private Labeling position at Advantage Medical Electronics, LLC?
Job Title: | Project Engineer, Private Labeling |
Department: | R&D |
Reports to: | VP, R&D, Quality & Regulatory Affairs |
FLSA | Exempt |
SUMMARY:
The Project Engineer for Private Labeling is responsible for driving the qualification and private labeling of specialized and/or niche 3rd party products into LifeSync’s product portfolio. These products play a vital role in ensuring that LifeSync has a comprehensive offering to meet the needs of all our customers.
The position works closely with other functions, especially Product Management, Supply Chain, Quality and Regulatory and external supplier teams. Responsibilities include helping identify potential sources of high-quality products, documenting specifications, performing product testing to internal and external standards, and creating/updating processes. Experience in design, electrical / mechanical testing and technical writing are important skillsets. The position requires a structured mindset, versatility and an emphasis on quality and execution.
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.
- Perform all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485 (2016), the Canadian Medical Device Regulations, and other regulatory requirements as embodied in the LifeSync QMS.
- Perform other related duties, as assigned.
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.
SUPERVISORY RESPONSIBILITIES: N/A
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).
PHYSICAL DEMAND:
Physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Stand, move, sit, talk/hear, vision, lift to ≤10 lbs.
WORK ENVIRONMENT:
- Typical Office/Production Environment
TRAVEL REQUIREMENT:
- Occasional (typically < 5%), including car or domestic flights.
- International flights unlikely, but possible.
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
LifeSync provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
The Age Discrimination in Employment Act (ADEA) forbids age discrimination against people who are age 40 or older. It does not protect workers under the age of 40, although some states have laws that protect younger workers from age discrimination. It is not illegal for an employer or other covered entity to favor an older worker over a younger one, even if both workers are age 40 or older.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
