Principal Design Quality Engineer

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

The Principal Design Quality Engineer opportunity is a leadership role responsible for ensuring the quality of products throughout the design and development process. This role will lead quality improvement initiatives, develop and implement quality plans and mentor other quality engineers all while fostering a culture of saftey and quality.

Key Accountabilities

• Authoring and overseeing quality plans that meet compliance standards, including those related to product design, saftey and reliability.
• Leading the process to ensure designs adhere to regulatory and quality requirements, including risk management activities.
• Overseeing design verification and validation activites, including testing, analysis and reviews.
• Leading and driving continious improvement initiatives to enhance product quality, efficiency and customer satisfaction.
• Providing leadership and mentorship to other engineers, fostering a culture of quality and saftey.
• Lead risk management initiatives for the entire product lifecycle in accordance with ISO 14971 and related regulatory requirements. Assure applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system.
• Support on-going product compliance technical documentation and on-going market authorization through review and response to competent authority feedback in a timely manner.
• Support teams to establish product development requirements (e.g. Design Input documents, design verification and validation requirements, risk management requirements, usability requirements, CTQ Identification, etc.)
• Serve as a Quality core team member on sustaining product lifecycle projects and new product development teams. Represent Quality for new and existing product improvement, manufacturing transfers, and quality plan intiatives
• Performs other duties and responsibilities as assigned
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
• Networking/Key relationships
• Working with cross-functional teams including Operations, Research and development, Regulatory Affairs, Marketing, and Quality Assurance.

Minimum Knowledge & Experience Required:

Education: Bachelor's degree in Engineering (Bio Medical Preferred) or related scientific field

Experience: 7 years (Preferrably Medical Device Industry)

Skills & Capabilities:

• Able to work in a team environment and collaborate
• Demonstrates knowledge of products, services, procedures, policies, systems and company organization as it relates to job requirements.
• Display PC skills with Microsoft Office (Word, Excel) and other desktop functions at an intermediate level.
• Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience.
• Excellent teamwork skills including influencing and building rapport with internal departments and stakeholders.
• Excellent problem solving skills, including demonstrated critical thinking skills and application of structured problem solving methods and tools.
• Able to lead and make independent decisions in collaboration with cross functional teams.

Travel Requirements:0%

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com