Sr. Quality Engineer, QA Design Assurance

Integrated DNA Technologies (IDT) is the leading manufacturer of custom oligonucleotides and proprietary technologies for genomics applications. Our work is complex and cutting-edge, and our team members are curious, creative thinkers who understand that good data drives smart decisions. At IDT, we realize that although science may be uniform, people are unique. We promote a culture where engaged people are motivated and have opportunities to achieve their full potential, as part of one global team. IDT is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. Job Title: Sr. Quality Engineer, QA Design Assurance Location: REMOTEWe believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working here can provide. Job Specific Duties/Essential Functions Participate in cross-functional teams as the Quality Engineering representative supporting all phases of product development, including software as a medical device, through design controls, risk management, usability, systems engineering, architecture, design verification and design validation.

Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA pre-submissions, 510k and IVDR CE certifications.

Facilitate and participate in product risk management process supporting documentation compliant with ISO 14971 such as hazard analysis, FMEAs, risk assessments, etc.

Work independently and with project team members to develop and improve product and processes to reduce variability and increase robustness throughout the development cycle for multiple projects

Assist technical teams in the assessment of design changes; including assessment, planning, verification and validation of the change and documentation as required.

Audit, identify and support implementation of Design process improvements.

Assist in preparation of global regulatory submissions, documentation, technical files, etc.

Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.

Act as resource for colleagues in explaining design control and risk management concepts and requirements; may include advising both technical teams and other QA Design Assurance team members on the best approaches to problems.

Demonstrates behavior consistent with the Integrated DNA Technologies Core Values.

Performs other duties as assigned.

Education, Licensure, Certification, Registration (Required vs. Preferred)Bachelor’s degree in science, medical, or technical field required.

Professional Experience (Required vs. Preferred)Minimum of 5 years of experience supporting design controls related to development of regulated medical devices with integrated software required; experience with software as a medical device preferred.

Strong working knowledge of ISO 13485, 21 CFR 820 and ISO 14971

Other Knowledge, Skills, and AbilitiesHighly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat

Demonstrated understanding of technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes

Must be detail oriented with well-developed organizational and analytical skills

Experiences in experimental design and assay development process is highly preferred

Experiences in software design and development process is preferred

Strong oral and written communication and presentation skills

Ability to identify, analyze and mitigate risk

What We Offer:Shift Differentials (Extra Compensation for less traditional shifts)

Generous Paid Time Off Accruals

16 Hours PAID Volunteer Time Off

11 Paid Holidays

Up to eight (8) weeks of 100% paid parental leave to eligible U.S. associates

401(k) with Company Match

Medical, Dental, and Vision Insurance Options

Integrated DNA Technologies (IDT) conducts drug screens and background checks on applicants who accept employment offers.When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.