Senior Compliance Engineer (ONSITE) at Stryker

Portage, Michigan, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s Degree in Electrical Engineering or related field
2+ years of related experience
Achieved an advanced (learning) level of industry knowledge (preferred)
Competent with Microsoft Office (Outlook, Excel, Word, etc.) (preferred)
Demonstrated competence and a beginner’s level of expertise in product design theory and application as applied specifically to electrical hardware and architecture, microcontroller, microprocessor, wireless technologies, embedded systems, and familiarity with mechanical components and products (preferred)
Demonstrated competence and a beginner’s level of expertise in electrical testing equipment and processes as well as an understanding and use of dynamic analytical methods/tools for analyzing electrical, software, and mechanical platforms (preferred)
General knowledge of compliance with the Code of Federal Regulations
General knowledge of Schematic Capture and PCB Layout tools (preferred)
Work within and apply standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-38, 2-52, IEC 60529, IEC 61000 Series, UL 60601-1, UL 746C, UL 1069, and additional ISO/AAMI related standards (preferred)
Willingness to travel 20%

Responsibilities

Educate the business on all aspects of compliance with US and international standards and regulations governing the manufacturing and selling of products
Facilitate the approvals process to gain and maintain market access
Serve as the system expert on test lab capabilities with respect to approvals testing processes and equipment
Assure product compliance while designs meet functional requirements and design inputs throughout the product life
Apply a broad knowledge of principles, practices, and procedures to verify product design conformance to US and international electrical and mechanical standards, regulations, and initiatives
Provide direction and support to lab personnel with respect to compliance testing, design, and sustainment of engineering teams in relation to compliance issues, and 3rd party labs with respect to product compliance testing
Develop and execute test plans with design, quality, and test teams
Collaborate with Electrical and Mechanical Test Engineers to ensure the correct test processes and procedures are followed to gain and maintain product compliance
Primary responsibilities for any equipment, processes, accreditation, documentation, or audits associated with internal certification, preliminary compliance, and compliance testing
Assist in designing and installing process sampling systems, procedures, statistical techniques, testing mechanisms, and equipment associated with compliance testing
Assist the design teams in analyzing acquired data and failures in order to provide actionable information to help improve design quality and efficiency with respect to compliance
Evaluate, recommend, procure and/or maintain various processes, procedures, architecture, equipment, programs, instrumentation and other technologies for continuous improvements in compliance or compliance testing
Act as a technical lead for design, sustainment engineering, and test team members, third party labs, or contractors as necessary

Skills

Compliance Testing

Electrical Standards

Mechanical Standards

Test Planning

Statistical Techniques

Audits

Accreditation

Data Analysis

Failure Analysis

Process Sampling

3rd Party Labs

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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