Easter Seals Jobs

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf)

Stryker is hiring a Staff Design Quality Engineer for our Spine division at either our Leesburg, VA or Allendale, NJ locations to support and partner with Engineering and Advanced Operations to define design requirements and develop manufacturing processes to support new product development projects. Lead risk management activities to ensure the highest level of product and process quality.

Who we want -

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.

• Data communicators . Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.

• Collaborative partners . People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.

What you will do:

• 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.

• Partner with 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 mitigate those issues throughout the development process.

• Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.

• Partner with Advanced Operations in the development of manufacturing processes 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 that 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.

What you will need

Required :

• BS in a science or an engineering discipline is required.

• Minimum of 5 years’ experience working in Design Quality or Research & Development (R&D) in a highly regulated environment with a preference in medical device with experience in new product development and design controls.

• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.

Preferred :

• MS, CQE, or CRE 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.

• 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).

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, Orthopaedics and Spine 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.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.