Principal Software Development Lifecycle (SDLC) Process Owner
Share
Job Location:
Portage, WI - USA
Monthly Salary:
$ 135600 - 293700
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
What You Will Do
Lead Ortho Techs SDLC processes ensuring compliance with Stryker policies regulations and industry standards.
Guide new product development teams in integrating SDLC design controls risk management and traceability into product and software development.
Champion Agile best practices (Scrum Kanban scaled Agile) and ensure alignment with SDLC and regulatory expectations.
Coach teams on incorporating compliance requirements into Agile iterations without impacting velocity or execution.
Establish and monitor Agile and SDLC metrics/KPIs to assess performance and drive continuous improvement.
Provide SDLC expertise and support for products across premarket and postmarket phases.
Lead SDLC initiatives represent the function on review boards and contribute to global and divisional process development.
Support and/or lead internal and external regulatory audits including narrative explanation preparation and logistics.
Provide training coaching and mentorship on software development SDLC processes and best practices.
Communicate progress risks and global SDLC initiatives to leadership and stakeholders while collaborating crossfunctionally across Ortho Tech.
What You Need (Required Qualification)
BS or Master in Software Engineering Computer Science or related discipline.
Minimum of 8 years experience expected.
Previous SDLC experience working in a highly regulated environment.
Preferred Qualifications (Strongly Desired)
Strong software development expertise with knowledge of U.S. and international SDLC regulations and standards (e.g. FDA MoH TUV ISO 13485 GDP GMP).
Excellent communication influencing and project management skills with the ability to manage multiple priorities.
Proven ability to represent SDLC effectively across crossfunctional teams and work collaboratively in a matrixed environment.
Strong interpersonal written verbal and negotiation skills.
Advanced analytical criticalthinking and problemsolving abilities.
Experience navigating compliancedriven environments and interacting with regulatory agencies.
$135600 - $293700 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
Travel Percentage: 20%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 contractors legal duty to furnish information.Required Experience:
Staff IC
Key Skills
- Mac Os
- Entertainment
- Desktop Support
- General Services
- Account Development
- Jewellery
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
