Job ID 20000A8P
Available Openings 1
PURPOSE AND SCOPE:
As part of Product Development team members who is responsible in engineering quality in the product and process design through appropriate application of Quality Engineering skill sets and thorough understanding of the product.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Work as part of product development team on new product development or on market design changes to ensure product quality and reliability, minimize risk to users and patients as well as regulatory and corporate SOP compliance.
- Reviews and approves verification and validation methods for non-sterile and/or sterile medical devices, including performance, biocompatibility, sterilization, software, and manufacturing processes to ensure design input is met.
- Determine testing sample size, confidence levels, and associated statistics pertaining to verification and validation activities.
- Responsible for Risk Management, development and utilization of Risk Management approach in Product Design and Manufacturing process changes and development.
- Perform Design Quality Assurance (Quality Engineering) function to build a comprehensive Design Assurance system compliant to FDA requirements in Design Control, and assisting in DHF deliverables development.
- Reviews product change notices and change documentation to ensure thorough review of quality documents submitted for product design changes or manufacturing changes conform to the Design Control requirements and satisfy product quality requirements.
- Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.
- Builds productive working relationships.
- May refer to senior level staff for assistance with higher level problems that may arise.
- Escalates issues to supervisor/manager for resolution, as deemed necessary.
- Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
- Assist with various projects as assigned by direct supervisor.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Occasional travel required
- Bachelor's Degree in Mechanical, Electrical, or Computer Engineering is required, Master's or PhD is preferred.
EXPERIENCE AND REQUIRED SKILLS:
- 0 – 2 years' related experience.
- If no experience, minimum GPA is 3.0
- Knowledge or experience with product or process design and development
- Knowledge or experience with FDA Design Controls
- Experience with identification of relevant compliance standards and associate testing.
- Demonstrated presentation and communication skills.
- Strong oral and written communication skills. Ability to communicate technical information to non-technical audiences.
- Proficient with PCs and Microsoft Office applications.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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