Mechanical Development Quality Engineer I

What You’ll Work On

• Execute and support on-time completion of Design Control Deliverables.

• Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.

• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities.

• Lead or support Risk Management activities from product Concept through Commercialization.

• Support design test and inspection method development, and lead method validation activities.

• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.

• Support manufacturing process development & qualification for new product commercialization and product changes.

• Support internal & external audit responses.

• Support product re-certifications.

• Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.

• Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications.

• Support execution of biocompatibility and sterilization qualifications.

• Complete Document Change Request Reviews in a timely and objective manner.

• Additional duties may be identified by functional management based on the current project/business objectives.

• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. •

• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelors Degree Or an equivalent combination of education and work experience

• Entry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position.

• Engineering experience (preferred)

• Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices. Knowledge of ISO 13485 standard. Knowledge of quality management techniques and application. Ability to clearly, concisely and accurately convey communications. Ability to form and develop interpersonal, professional relationships. Display socially and professionally appropriate behavior. Ability to work independently and in groups. Ability to work cross-functionally. Demonstrated initiative and problem-solving skills. Critical-thinking skills. Ability or aptitude to use various types of databases and other computer software. Strong organizational skills. Ability to prioritize. Ability to multitask. Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives. Ability to quickly gain knowledge, understanding or skills and is willing to learn.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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