Stryker
Senior Manager, Compliance Engineering (Hybrid)
Stryker, Portage, Michigan, United States, 49002
Stryker is seeking a
Senior Manager, Compliance Engineering
within our
Medical Division
. This is a hybrid position located in
Portage, MI
.
As the
Senior Manager, Compliance Engineering
you will lead the Compliance Engineering function, ensuring all products meet applicable regulatory and industry standards for safety, electromagnetic compatibility (EMC), wireless performance, and electrical compliance. This role provides strategic and technical leadership in compliance testing and certification processes, with a strong focus on
IEC 60601 series standards
and applicable national and international regulations.
This position sits within the
RAQAC Business
as part of the
Systems and Technical Solutions team
, a shared service supporting multiple business units within the
Medical Division
.
What you will do
Lead and develop a high-performing Compliance Engineering team, including EMC, Safety, and Wireless engineers.
Ensure product compliance with standards such as
IEC 60601
and regional/national deviations (e.g., ANSI/AAMI, CAN/CSA, EN, JIS).
Develop and execute optimized test strategies using internal certified labs and external testing partners (e.g., UL, Intertek, CSA).
Collaborate with Product Development teams to align design controls and verification plans with compliance requirements.
Maintain and improve compliance engineering processes and SOPs aligned with
ISO 13485
,
21 CFR 820
, and internal QMS.
Stay current with evolving global standards and proactively update internal processes and documentation.
Manage compliance budgets, capital equipment needs, and vendor relationships.
Support cross-functional teams (Marketing, Operations, Service) in understanding product compliance claims and limitations.
What you need
Required
Bachelor's degree in an Engineering-related discipline
10+ years of experience in Engineering, Quality, or Regulatory disciplines
4+ years of people management experience
Preferred
Experience in FDA-regulated or highly regulated environments
Deep understanding of IEC standards for medical devices, especially
IEC 60601-1
and
IEC 60601-2-4
Skilled performance coach with experience in setting clear objectives and managing team performance
Strong familiarity with technical documentation files and safety agencies (UL, CSA, TUV, CB-Scheme)
Proven ability to deliver programs or business goals on time, within budget, and to quality standards
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.
Senior Manager, Compliance Engineering
within our
Medical Division
. This is a hybrid position located in
Portage, MI
.
As the
Senior Manager, Compliance Engineering
you will lead the Compliance Engineering function, ensuring all products meet applicable regulatory and industry standards for safety, electromagnetic compatibility (EMC), wireless performance, and electrical compliance. This role provides strategic and technical leadership in compliance testing and certification processes, with a strong focus on
IEC 60601 series standards
and applicable national and international regulations.
This position sits within the
RAQAC Business
as part of the
Systems and Technical Solutions team
, a shared service supporting multiple business units within the
Medical Division
.
What you will do
Lead and develop a high-performing Compliance Engineering team, including EMC, Safety, and Wireless engineers.
Ensure product compliance with standards such as
IEC 60601
and regional/national deviations (e.g., ANSI/AAMI, CAN/CSA, EN, JIS).
Develop and execute optimized test strategies using internal certified labs and external testing partners (e.g., UL, Intertek, CSA).
Collaborate with Product Development teams to align design controls and verification plans with compliance requirements.
Maintain and improve compliance engineering processes and SOPs aligned with
ISO 13485
,
21 CFR 820
, and internal QMS.
Stay current with evolving global standards and proactively update internal processes and documentation.
Manage compliance budgets, capital equipment needs, and vendor relationships.
Support cross-functional teams (Marketing, Operations, Service) in understanding product compliance claims and limitations.
What you need
Required
Bachelor's degree in an Engineering-related discipline
10+ years of experience in Engineering, Quality, or Regulatory disciplines
4+ years of people management experience
Preferred
Experience in FDA-regulated or highly regulated environments
Deep understanding of IEC standards for medical devices, especially
IEC 60601-1
and
IEC 60601-2-4
Skilled performance coach with experience in setting clear objectives and managing team performance
Strong familiarity with technical documentation files and safety agencies (UL, CSA, TUV, CB-Scheme)
Proven ability to deliver programs or business goals on time, within budget, and to quality standards
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.