Sr. Engineer, Design Controls - Defined Term

Getinge

  • Wayne, NJ
  • $115,000-140,000 per year
  • Permanent
  • Full-time
  • 8 days ago
With a passion for lifeJoin our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.Are you looking for an inspiring career? You just found it.Job OverviewWe are seeking a highly motivated and detail-oriented Quality System Design Control Specialist for a 12-month defined term assignment. This role will be instrumental in enhancing and harmonizing our design control processes across hardware and disposable product lines, ensuring alignment with corporate directives and regulatory expectations for medical devices.Job Responsibilities and Essential Duties
  • JAMA Integration: Lead the implementation of JAMA into existing Design Control SOPs, ensuring seamless integration and usability across teams.
  • Change Management: Develop and manage Management System Plans to support the implementation of changes within Design Controls.
  • Process Harmonization: Unify and streamline design control procedures for both hardware and disposable product lines to ensure consistency and compliance.
  • Strategic Vision: Design effective and efficient processes that enable delivery of safe and effective medical devices.
  • Cross-Functional Linkages: Maintain and enhance linkages between Design Controls and other Quality Management System (QMS) processes.
  • Corporate Alignment: Ensure all design control activities align with overarching corporate directives and quality strategies.
  • Training & Engagement: Conduct periodic open-dialogue training sessions to build organizational knowledge and reinforce best practices in design control.
  • Communication & Collaboration: Act as a strong listener and communicator, fostering collaboration across departments and levels.
Minimum Requirements
  • Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
  • 5+ years of experience in Quality Systems or Design Control within the medical device industry.Proven experience with JAMA or similar requirements management tools.
  • Strong understanding of FDA QSR, ISO 13485, and EU MDR requirements.
  • Excellent interpersonal, communication, and facilitation skills.
  • Demonstrated ability to lead cross-functional initiatives and drive process improvements.
Required Knowledge, Skills, and Abilities
  • Strong understanding of FDA QSR, ISO 13485, and EU MDR requirements.
  • Excellent interpersonal, communication, and facilitation skills.
  • Demonstrated ability to lead cross-functional initiatives and drive process improvements
This is a “Defined Term” assignment that will last approximately 12 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.Salary range: $115-140K Annually#LI-LG1About usWith a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.Benefits at Getinge:At Getinge, we offer a comprehensive benefits package, which includes:
  • Health, Dental, and Vision insurance benefits
  • 401k plan with company match
  • Paid Time Off
  • Wellness initiative & Health Assistance Resources
  • Life Insurance
  • Short and Long Term Disability Benefits
  • Health and Dependent Care Flexible Spending Accounts
  • Commuter Benefits
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Getinge