Leads design quality and manufacturing investigations, including root-cause analysis, CAPA, NCRs, risk management, design controls, verification and validation. Applies DOE, FMEA, HACCP, statistical analysis, acceptance sampling, and gage R&R. Supports medical device quality systems, post-market surveillance, regulatory compliance, process validation, and design history files. Mentors junior staff, reviews technical documentation, coordinates major projects, and oversees testing and product release activities.
PURPOSE AND SCOPE:
Coordinates all efforts for major projects and other significant assignments. Assists in performing disciplined problem solving for supplier, customer, and internal quality defect. Plays an active role in supporting design control activities, concept through release.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Coordinates timely and complete investigations within the assigned manufacturing plant.
- Ensures compliance to all state and Federal regulations and requirements.
- Composes and executes design and process verification and validation protocols and reports. Reviews and approves protocols and reports written by other staff as appropriate.
- Investigates root cause solutions for product release through nonconformance reports (NCR), corrective and preventative actions (CAPA), and material containment and hold forms (MCH) and affected lot hold forms (ALH).
- Utilizes basic statistical techniques, Experimental Design (DOE), Risk Management, Hazard Analysis and Critical Control Point (HACCP), and Failure Modes and Effects Analysis (FMEA). Conducts and interprets Gage Reproducibility and Repeatability (R&R) studies.
- Provides support in coordinating plant risk management activities and ensuring risk management techniques are implemented throughout product lifecycle.
- May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
- May escalate issues to supervisor/manager for resolution, as deemed necessary.
- May manage and execute testing and release procedures for finished products.
- Mentors other staff as applicable.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Assists with various projects as assigned by a 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.
Ability to lift up to 50 lbs. as required.
The employee may also be exposed to bovine and human blood products. Hepatitis B Vaccination is recommended.
EDUCATION:
Bachelor’s Degree required; Advanced Degree desirable.
EXPERIENCE AND REQUIRED SKILLS:
- Minimum 5 – 8 years of related experience; or a Master’s degree with 3 years’ experience.
- Strong analytical & troubleshooting skills.
- Ability to understand and employ mathematics at an engineering or scientific level.
- Strong technical report writing skills.
- Ability to read, analyze, interpret common scientific and technical reports, technical procedures, governmental regulations.
- Experience with Correlation and regression Analysis, Experimental Design (DOE), and acceptance sampling; as well as conducting and interpreting gage R&R studies.
- Strong oral and written communication skills.
- Strong computer skills, proficient with Microsoft Office.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
ADDENDUM:
Engineer/Risk Management focus
- Deep understanding and experience with Risk Management techniques associated with ISO14971-2019. Includes creation of Risk Management Plans, Hazard Analysis/Risk Analysis, Risk Management Reports.
- Understanding Risk linkages to CAPAs, SCARs, NCMRs, complaint handling, and overall quality system.
- Understanding and experience of applying Risk Activities required to support post-market surveillance.
- Understanding and experience applying supportive risk management tools such as dFMEAs, pFMEAs, Use Error Analyses, SW Risk analyses.
- Understanding and applying use of Harms libraries, P1 values, P2 values in premarket and post market settings.
- Ability to review and oversee quality system procedures related to risk management and risk related techniques.
Engineer/Design Assurance Focus
- Deep understanding and experience with Design Control techniques including Design Planning, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, Design Changes, Design Transfer, and Design History Files (Design and Development Files).
- Understanding and experience with applying Design Control linkages to Mfg. Process development and Process Validation.
- Understanding and experience with how Design Controls link into other facts of a quality management system.
- Understanding and experience applying Statistical Techniques in a Design Control context for Design Verification and Validation.
- Understanding of Human Factors/Usability Engineering processes and techniques.
The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.
Annual Rate: $117,000.00 - $196,000.00
Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance.
Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.
Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factorsFresenius Medical Care Boston, Massachusetts, USA Office
Boston, United States
Fresenius Medical Care Waltham, Massachusetts, USA Office
Waltham, United States
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