Sr Staff Engineer, Windchill PLM

Portage - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Work Flexibility: Hybrid or Onsite

Senior Staff Specialist Windchill PLM

Stryker is hiring aSenior Staff Specialist Windchill PLMinPortage MIto lead the technical execution development and continuous improvement of the Windchill (onePLM) system for our Instruments Division. This role includes mentoring global Business Admins overseeing Quality Management System (QMS) compliance with medical device regulations and collaborating with Global Process Owners to implement and maintain quality and regulatory processes across our global systems all within a fast-paced innovative environment.

What you will do:

Lead the research design development and evaluation of complex medical device systems.
Apply advanced engineering principles and mentor others in technical concepts and practices.
Translate user needs into system requirements and develop test architectures.
Allocate and decompose requirements across electrical mechanical and software disciplines using modeling and analysis techniques.
Guide concept phase activities and resolve complex product design challenges.
Conduct analytical studies including trade-offs optimizations and performance assessments.
Lead system integration testing and verification and contribute to product risk management.
Manage validation activities (IQ OQ PQ) change control CAPA/NC actions and ensure compliance with QMS and regulatory standards.

What you will need:

Required:

Bachelors degree in science engineering business or related discipline.
8 years of experience in manufacturing environment or equivalent.
Experience in regulated environment and interaction with regulatory agencies.
Knowledge of Quality Systems (CAPA audits Management Review Quality Planning etc.)

Preferred:

Experience in developing and optimizing complex systems
Knowledge of the Quality System Regulations (21 CFR Part 820) and ISO 13485 Regulations as it relates to change management.
Thorough knowledge and understanding of US and International Medical Device Regulations.

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 contractors legal duty to furnish information.

Required Experience:

Staff IC

Work Flexibility: Hybrid or OnsiteSenior Staff Specialist Windchill PLMStryker is hiring aSenior Staff Specialist Windchill PLMinPortage MIto lead the technical execution development and continuous improvement of the Windchill (onePLM) system for our Instruments Division. This role includes mentorin...

Work Flexibility: Hybrid or Onsite

Senior Staff Specialist Windchill PLM

What you will do:

Lead the research design development and evaluation of complex medical device systems.
Apply advanced engineering principles and mentor others in technical concepts and practices.
Translate user needs into system requirements and develop test architectures.
Allocate and decompose requirements across electrical mechanical and software disciplines using modeling and analysis techniques.
Guide concept phase activities and resolve complex product design challenges.
Conduct analytical studies including trade-offs optimizations and performance assessments.
Lead system integration testing and verification and contribute to product risk management.
Manage validation activities (IQ OQ PQ) change control CAPA/NC actions and ensure compliance with QMS and regulatory standards.

What you will need:

Required:

Bachelors degree in science engineering business or related discipline.
8 years of experience in manufacturing environment or equivalent.
Experience in regulated environment and interaction with regulatory agencies.
Knowledge of Quality Systems (CAPA audits Management Review Quality Planning etc.)

Preferred:

Experience in developing and optimizing complex systems
Knowledge of the Quality System Regulations (21 CFR Part 820) and ISO 13485 Regulations as it relates to change management.
Thorough knowledge and understanding of US and International Medical Device Regulations.

Travel Percentage: 10%

Required Experience:

Staff IC

Key Skills

Computer Science
Docker
Kubernetes
Python
VMware
C/C++
Go
System Architecture
gRPC
OS Kernels
Perl
Distributed Systems

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About Company

Stryker

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

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