Senior Engineer - Software Design Assurance in Davie, FL at Stryker Corporation

Date Posted: 5/15/2020

Job Snapshot

Job Description

Who we want

  • Patient-oriented achievers. Engineers with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.
  • Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.
  • Challengers & Influencers.  People who constantly challenge themselves and each other to achieve more & to win the right way.
  • Teammates.  Partners who listen to ideas, share thoughts and work together to move the business forward.

What you will do

As a Senior Software Design Assurance Engineer, you will develop and implement methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Analyze reports and defective products to determine trends and recommend corrective actions. Collaborate with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs.

Responsibilities:

  • Partner with cross functional project teams to lead product and/or process planning, design and development activities 
  • Partner with Product Development to define requirements that will ensure appropriate level of rigor to software validation 
  • Lead Risk Management activities throughout the product development life cycle 
  • Partner with Product Development to perform risk evaluation of product design and to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria 
  • Provide guidance to the development team through Software Development and New Product Development process including demonstrating understanding of software lifecycle methodologies (e.g. Waterfall, Agile). 
  • Develop quality assurance documentation to support regulatory submissions 
  • Lead quality system maintenance for the division by identifying and correcting deficiencies in our procedures and practices  
  • Manage, lead and/or assist in resolving nonconformities and corrective actions/preventive actions (CAPA) 
  • Participate in internal and external compliance audits 

What you will need

  • Bachelors Degree or equivalent work experience in a software related role
  • 2 + years experience working in a highly regulated environment, software related role, engineering, quality, manufacturing or new product development.

Preferred Qualifications:

  • Bachelor’s Degree in Computer Science or related field of study strongly preferred
  • Prefer CQE certification or equivalent and Six Sigma Green or Black Belt
  • Experience as a Quality Engineer (QE) in a regulated design environment
  • Knowledge of medical device product development life cycle, including risk management and design/ process verification & validation and computer software validation.
  • Knowledge of FDA QSRs, ISO 13485 Design Control Procedures, IEC 62304 and ISO 14971 

Work From Home: Occasional

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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