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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
- Lead Risk Management Team
- Lead HCP interactions
- Lead Human Factors Engineering activities
- Lead validation of user needs with surgeons & nurses
- Develop quality assurance documentation to support new product development process and regulatory submissions.
- Lead quality system maintenance by identifying and correcting deficiencies in procedures and practices.
- Influence cross-functional project teams to lead product and/or process design and development activities.
- Lead risk management activities for new product development projects.
- Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership.
- Present risks associated with the product use during Design Reviews and track the design, documentation, and manufacturing process to mitigate those issues throughout the development process.
- Influence new product development teams when defineing design verification and validation test requirements to ensure design inputs and safety requirements are met.
- Influence Advanced Operations in the definition and development of manufacturing processes and process controls for new products.
- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, establish process parameters, resolve quality problems, etc.
- Develop, review, and approve inspection plans, routers, and product drawings for new products.
- Support product design transfers to internal and/or external manufacturing facilities.
- Provide support and direction for other Quality Engineers.
- Evaluate predicate products for relevant quality issues tthat may impact new product development projects.
- Analyze and define critical quality attributes for product and process through risk analysis techniques.
- Participate in collection of initial market feedback on new products and address early concerns.
- Contribute to the completion of final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
- BS in a science, engineering or related discipline.
- MS preferred., CQE or CRE desired
- Minimum of 7 years experience preferred
- Medical device or practical HCP experience preferred
- Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
- Demonstrated ability to read and interpret CAD drawings.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
- Thorough knowledge and understanding of US and International Medical Device Regulations.
- Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
- Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.
- Demonstrated ability to advocate for product excellence and quality.
- Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Strong in critical thinking and "outside the box" thinking.
- Highly developed problem solving skills. Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently.
- Experience in working in a compliance risk situation.
- Computer literacy (including proficiency with Mini-Tab or similar analysis program).
- Some travel may be required.
Health benefits include: Medical and prescription drug insurance, dental
insurance, vision insurance, critical illness
insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing
program and
tobacco cessation program.
Financial benefits include:Health Savings Account (HSA),
Flexible Spending Accounts (FSAs),
401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability
insurance.
Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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