Design Quality Assurance Engineer at Stryker

Lund, Skane County, Sweden

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

BS in a science, engineering or related discipline. MS preferred
4+ years work experience in relevant field
Good written and verbal communication skills in English and Swedish
Preferred Qualifications
Experience with medical device product development lifecycle, including risk management and design/process verification and validation and associated standards
Experience in interacting with regulatory agencies (FDA, MoH, Notified Bodies, etc.)
Thorough knowledge and understanding of US and Global Medical Device Regulations
Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics)
Strong project management skills as well as the ability to manage multiple tasks simultaneously
Demonstrated ability to advocate for product excellence and quality
Demonstrated ability to effectively work cross-functionally with other departments, including Product Development, Regulatory Affairs, and Marketing

Responsibilities

Develop quality assurance documentation to support new product development process, sustaining engineering activities and regulatory submissions
Partner with cross-functional project teams to lead product and/or process design and development and change activities
Lead risk management activities for new product development projects and engineering changes
Evaluate overall residual risk for products prior to launch and present final risk/benefit justification to executive leadership
Present risks associated with the product use and track how the design, documentation, and manufacturing process mitigate those issues throughout the development process
Partner with cross-functional project teams to define design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria
Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits, resolve quality problems, etc
Contribute to the completion of final design verification and validation reports
Develop, review, and approve documents as needed
Support product design transfers to internal and/or external partners
Engage in quality system maintenance by identifying and correcting deficiencies in procedures and practices
Provide support and direction for other Quality Engineers
Analyze and define critical quality attributes for product through risk analysis techniques
Participate in collection of initial market feedback on new products and address early concerns

Skills

Key technologies and capabilities for this role

Risk ManagementQuality AssuranceDesign VerificationDesign ValidationStatistical AnalysisProblem-SolvingRegulatory SubmissionsProduct Development

Questions & Answers

Common questions about this position

What are the minimum qualifications for the Design Quality Assurance Engineer role?

Candidates need a BS in a science, engineering or related discipline (MS preferred), 4+ years of work experience in a relevant field, and good written and verbal communication skills in English and Swedish.

Is this a remote or hybrid position?

This is a hybrid position.

What preferred experience is valuable for this role?

Preferred qualifications include experience with medical device product development lifecycle (risk management, design/process verification and validation), interacting with regulatory agencies like FDA and Notified Bodies, knowledge of US and Global Medical Device Regulations, strong project management skills, and ability to work cross-functionally.

What is the salary for this position?

This information is not specified in the job description.

How much travel is required in this role?

The role requires 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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