Staff R&D Engineer - Sustaining & Model Development at Stryker

Irvine, California, 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 Mechanical Engineering, Biomedical Engineering or related discipline
4+ years of work experience in a regulated industry
Proficient in 3D CAD modeling (Solidworks Preferred)
Experience with design control
Experience in creating engineering drawings, models, applying GD&T, and CAE tools to optimize the design (Preferred)
Adept at applying knowledge of materials and manufacturing processes to product design (Preferred)
Pre-clinical and/or clinical experience (Preferred)
510(k) and/or PMA experience (Preferred)

Responsibilities

Independently research, design, develop, modify, and verify mechanical components for medical devices while working cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success
Conduct or design advanced prototyping and testing
Create benchtop models to simulate clinically relevant and challenging use conditions
Support Voice of Customer sessions internally and with clinicians
Analyze and correct complex product design issues using independent judgment. Ensure traceability and compliance with requirements, including ISO 13485, EUMDR, and other international regulations
Support and execute segments of complex multifunctional teams to advance post-launch design changes at the material, component, and supplier level
Lead creation and refinement of engineering documentation, such as the Design History file
Follow and mentor others on R&D procedures like design controls and risk management, per the Quality Management System

Skills

Key technologies and capabilities for this role

Solidworks3D CADMechanical DesignPrototypingTestingDesign ControlsRisk ManagementISO 13485EUMDRDesign History File

Questions & Answers

Common questions about this position

What is the salary range for the Staff R&D Engineer position?

The salary range is $100k - $165k plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Is this role remote or onsite?

The position requires onsite work.

What are the required qualifications for this role?

Candidates need a Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering or related discipline, 4+ years of work experience in a regulated industry, and proficiency in 3D CAD modeling (Solidworks preferred).

What is the expected travel percentage for this position?

The role involves up to 20% travel.

What experience makes a candidate stand out for this Staff R&D Engineer role?

Preferred qualifications include experience in creating engineering drawings, models, applying GD&T, and CAE tools; knowledge of materials and manufacturing processes; pre-clinical/clinical experience; and 510(k)/PMA experience.

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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