Senior Staff Product Safety Engineer (Hybrid)
Company: Stryker Group
Location: Portage
Posted on: March 19, 2023
Job Description:
Why engineering at Stryker? At Stryker we are dedicated to
improving lives, with a passion for researching and developing new
medical device products. As an engineer at Stryker,you will be
proud of the work that you will be doing, using cutting-edge
technologies to make healthcare better.Here,you will work in a
supportive culture withotherincredibly talented and
intelligentpeople, creating industry-leading medical technology
products. You will also have growth opportunities as we have a
culture that supports your personal and professional development.
Need another reason to apply? Check out these 8 reasons to join
Stryker's engineering team: We are proud to be named one of the
World's Best Workplaces and a Best Workplace for Diversity by
Fortune Magazine! Learn more about our award-winning organization
by visiting Our benefitsinclude bonuses; commissions; healthcare;
insurance benefits; retirement programs; stock based plans; family
and parenting leaves; tuition reimbursement; wellness programs;
onsite fitness centers and cafeterias; discount purchase programs;
and service and performance awards - not to mention various social
and recreational activities. Job Description Summary:The Senior
Staff Engineer - Product Safety will help bring to market our next
generation of industry leading products across the Stryker
Instruments portfolio. In this role, you will work with a
cross-functional leadership team to support the development and
execution of the Product Safety organization's strategic vision,
enabling the consistent execution of safety activities for all
products throughout the entire product life-cycle. You will be a
recognized expert and leader within the specialized field of
Product Safety engineering, demonstrating passion for system design
and mentoring others.Who we want:
- Analytical problem solvers.People who go beyond just fixing to
identify root causes, evaluate optimal solutions, and recommend
comprehensive upgrades to prevent future issues.
- Dedicated achievers.Relentless about quality, people who thrive
in a fast-paced environment and will stop at nothing to ensure a
project is complete and meets regulations and expectations.
- Collaborative partners.People who build and leverage
cross-functional relationships to bring together ideas,
information, use cases, and industry analyses to develop best
practices.What you will do:Technical Responsibilities:--- Lead or
mentor design and development of electrical components,
sub-systems, and/or systems for medical devices--- Apply and mentor
others on advanced engineering theories, principles, and
concepts--- Conduct, design, and select advanced prototyping and
testing--- Lead and guide in correction of complex product design
issues--- Conduct technology exploration and influence application
in the business--- Translate user needs to design inputs/
specifications and produce complex system level designs
independently--- Develop a number of invention disclosures, patents
or trade secrets--- Independently make design tradeoff decisions
while designing multiple components of the systemBusiness
Responsibilities:--- Contribute to competitive and market strategy
by demonstrating in-depth knowledge of the market, customer
dynamics and competitive offerings--- Apply strong understanding of
clinical procedures to enhance product development--- Contribute to
and execute customer facing activities like voice of customer and
customer centric design in partnership with internal and external
stakeholders--- Demonstrates financial acumen.Med Device
Compliance:--- Mentor others as a business unit expert on the usage
of industry standards, including design requirements and test
strategies per applicable regulations--- Lead others to create and
refine engineering documentation, such as the Design History file
and creates more progressive technical content--- Contribute to
R&D procedures and development of industry standards working
closely with cross-functional business unitsGeneral
Responsibilities:--- Work cooperatively with R&D, Quality,
Manufacturing, Regulatory, Clinical, Marketing and Project
Management to ensure project success, both leading and influencing
other leaders on the team--- Identify and lead the creation of or
improvements to procedures, policies, processes, systems, and
technology required--- Execute and lead segments of complex product
development to advance projects through the design
/development/launch process--- Contribute to complex product
development through release and lead one technical area of
expertise--- Hold self and others accountable to deliver high
quality results with passion, energy and drive to meet business
priorities--- Mentor, develop and inspire others in current and
future rolesMinimum Qualifications (Required):--- Bachelor's Degree
in Electrical Engineering, Computer Engineering, Systems
Engineering, or a related Engineering degree from an accredited
college or university.--- Minimum of 6 years of engineering
experiencePreferred Qualifications (Strongly desired):Technical
Skills:---Possess an understanding of IEC standards and
understanding of compliance or related regulatory compliance
standards.
- Viewed as a divisional resource in area of expertise.
- Must possess excellent oral and written communication
skills.
- Competent with Microsoft Office (Outlook, Excel, Word,
etc.).
- Demonstrated competence and an intermediate level of expertise
in product design theory and application as applied specifically to
electrical hardware and architecture, microcontroller,
microprocessor, wireless technologies, embedded systems but also
familiarity with mechanical components and products.
- Work within and apply the following standards in the
development of our products (not limited to the below standards):
- IEC 60601-1 (General Safety Requirements for Medical Electrical
Equipment)
- IEC 60601-1-2 (EMC)
- IEC 60529 (Ingress Protection for Enclosures)
- IEC 61000 Series (EMC Testing Techniques)
- UL 746C (Polymeric Material Used In Electrical Equipment)
- (Audio/video, information and communication technology
equipment - Part 1: Safety requirements)
- IEC 61010-1 (Safety requirements for electrical equipment for
measurement, control, and laboratory use - Part 1: General
requirements)
- ISO 17025 (General Requirements For The Competence Of Testing
And Calibration Laboratories)About Stryker Stryker is one of the
world's leading medical technology companies and, together with our
customers, is driven to make healthcare better. The company offers
innovative products and services in Medical and Surgical,
Neurotechnology, Orthopedics, and Spine that help improve patient
and healthcare outcomes.Alongside its customers around the world,
Stryker impacts more than 100 million patients annually. More
information is available at
Keywords: Stryker Group, Gary , Senior Staff Product Safety Engineer (Hybrid), Engineering , Portage, Indiana
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