Staff Engineer, Design Validation at Stryker

Fort Lauderdale, Florida, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, MedTechIndustries

Requirements

Bachelor’s degree in Biomedical Engineering, Electronic/Electrical Engineering, Human Factors Engineering, or Lifesciences discipline
4+ years of industry experience validating complex hardware/software or systems
Experience within the medical device industry

Responsibilities

Collaborate with cross-functional teams to develop user needs that drive objective validation studies
Lead design validation activities including preparing stimulated use environments, defining sample size and acceptance criteria, and managing participant recruitment for Digital, Robotics, and Enabling Tech products
Develop and validate clinically relevant use cases for navigated and robotic orthopedic procedures by engaging with KOLs and observing clinical procedures
Apply in-depth knowledge of the operating room environment and complex medical technology to perform clinically relevant design validation testing
Participate in user-centric development activities and confirm user needs are met in device design, packaging, labeling, and training
Use Systems Engineering Principles to drive best practices in User Needs, Requirements, and V&V activities
Collaborate with cross-functional teams such as Medical Education and Marketing to mimic field-training for medical device launch
Ensure all design validation activities comply with relevant regulations, standards, and industry best practices

Skills

Key technologies and capabilities for this role

Design ValidationSystems EngineeringUser Needs ResearchV&VFDA GuidanceIEC 62366Human Factors EngineeringRoboticsBiomedical EngineeringMedical Device RegulationsRequirements Engineering

Questions & Answers

Common questions about this position

What is the work arrangement for this position?

The position offers hybrid work flexibility.

What are the required qualifications for this role?

Candidates need a Bachelor’s degree in Biomedical Engineering, Electronic/Electrical Engineering, Human Factors Engineering, or Lifesciences discipline, plus 4+ years of industry experience validating complex hardware/software or systems, and experience within the medical device industry.

What preferred skills are highlighted for this Staff Engineer role?

Preferred qualifications include a strong understanding of medical device regulations like FDA Guidance, IEC 62366, 60601-1-6, HE75, experience in User Needs Research, Design validation, med tech product development, excellent problem-solving, analytical and communication skills, and strong collaborative and leadership skills.

How much travel is required in this position?

The role requires up to 20% travel.

What makes a strong candidate for this Staff Engineer position?

A strong candidate will have the required degree and experience in medical device validation, plus preferred expertise in regulations, user needs research, and cross-functional collaboration skills.

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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