Senior Design Quality Engineer (Software/Electrical) at Stryker

Portage, Michigan, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DeviceIndustries

Requirements

Bachelor’s degree in Software Engineering, Electrical Engineering, Computer Science Engineering, Biomedical Engineering, or related field with relevant experience
2+ years of experience in quality, manufacturing, new product development, software, or engineering
Candidates must reside within a commutable distance to Portage, MI and be able to work onsite several times per week (Hybrid)
Willingness to travel 10%
Preferred Qualifications
Experience in the medical device or manufacturing industry
Familiarity with ISO 13485 and ISO 14971 standards
Knowledge of statistical analysis tools (e.g., Minitab) and advanced quality tools (FMEA, GD&T, Root Cause Analysis)
Experience with Software Development and Connectivity technology such as Wi-Fi, Bluetooth, UWB (ultra wide band)
Ability to read and interpret CAD drawings
Six Sigma certification

Responsibilities

Ensure product designs meet quality, safety, and effectiveness requirements by partnering with R&D and cross-functional teams
Lead risk management activities for new product development, including creating plans, conducting reviews, and verifying risk controls
Execute design validation activities, including human factors engineering and usability testing
Collaborate with Product Security and R&D teams to implement cybersecurity best practices in product design
Participate in design reviews and track risk mitigation throughout development and manufacturing processes
Support product design transfers to internal and external manufacturing facilities
Analyze and define critical quality attributes for products and processes using risk analysis techniques
Partner with suppliers and manufacturing to implement robust process controls and quality improvements

Skills

Key technologies and capabilities for this role

ISO 13485ISO 14971Risk ManagementFMEAHuman Factors EngineeringUsability TestingCybersecurityGD&TRoot Cause AnalysisMinitabStatistical Analysis

Questions & Answers

Common questions about this position

Is this position remote or hybrid?

The position is hybrid, and candidates must reside within a commutable distance to Portage, MI and be able to work onsite several times per week.

What are the required qualifications for this role?

A Bachelor’s degree in Software Engineering, Electrical Engineering, Computer Science Engineering, Biomedical Engineering, or related field with relevant experience, plus 2+ years of experience in quality, manufacturing, new product development, software, or engineering are required.

What is the salary range for this position?

This information is not specified in the job description.

What preferred skills or experiences are highlighted?

Preferred qualifications include experience in the medical device or manufacturing industry, familiarity with ISO 13485 and ISO 14971 standards, knowledge of statistical analysis tools like Minitab, advanced quality tools such as FMEA and Root Cause Analysis, software development with connectivity tech like Wi-Fi and Bluetooth, ability to read CAD drawings, and Six Sigma certification.

How much travel is required for this role?

The role requires up to 10% travel.

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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