Danaher Corporation Program Manager - Innovation Technology Core in Sunnyvale, California
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Program Manager – Innovation Technology Core is responsible to ensure that Innovation technology core research programs and associated projects for new systems, instruments and software within a medical device and/or molecular in-vitro diagnostic company are designed to improve customer experience and meet global commercial expansion strategies.
This position will be located at the site in Sunnyvale, CA. In this role you will have the ability to work on new transformative technology within the Innovative Technology Core group. These programs are early stage research and initial prototypes and need to ensure appropriate hand-off to New Product Development core teams that will begin the design control tracing for the product.
In this role, you will have the opportunity to:
Responsible for the entire life cycle, including cost, schedule and technical performance, of assigned program/portfolio(s).
This role will be responsible for leading disruptive technology design and developments for medical diagnostic systems
Track, monitor and trend multiple projects and programs for Innovation technology core systems, including instruments, components and software
Collect, assess and track Design for Excellence (DFX) opportunities on early engineering protypes (ie manufacturability, reliability and serviceability improvements).
Lead Innovation Assessment Index scoring meetings for Innovation Technology Core.
Draws upon technical knowledge in the fields of science or engineering, and a diverse amount of expertise in managing projects in a multi-disciplinary environment.
Establishes design concepts, criteria and engineering efforts for product research, development, marketing, integration and test.
The essential requirements of the job include:
Bachelor’s degree with 5+ years of experience working in a global regulatory environment, preferably IVD, Master’s degree with 3+ years of experience OR PhD with 0-2 years of experience
Engineering design or development experience
Previous experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003.
It would be a plus if you also possess previous experience in:
Degree(s) preferred in Engineering, Systems Engineering or Bio-engineering with strong technical background, preferably in the in vitro diagnostics or medical device industry
Experience in clinical or hospital laboratory management/operations or public health a plus
Broad global understanding of regulatory medical device requirements.
Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 tools and the stability of a tested organization.
Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 202.419.7762 or email@example.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid