Talantix.io
SkyWater Search Partners•11.02.26
AI SCORE 8.5

Senior Design Assurance Engineer - MedTech Focus

$150K/year
HybridMedTechRelocation
ISO 14971•HIPAA•GDPR•DFMEA•MS Office•Jira

About the Role

We are seeking a Senior Design Assurance Engineer to join our dynamic team at SkyWater Search Partners. This Senior Design Assurance Engineer remote position offers an exciting opportunity to advance your career in the MedTech industry while receiving relocation support. You will play a crucial role in ensuring quality for non-device applications and device-adjacent software in Class III implants.

What You'll Do

  • Champion quality assurance processes for software applications, ensuring compliance with IEC 62304 and FDA regulations.
  • Collaborate cross-functionally to audit deliverables and drive risk management initiatives.
  • Validate test environments and enforce compliance throughout the product lifecycle, from concept to commercialization.
  • Mentor and lead a growing team, tackling audits, Engineering Change Orders (ECOs), and cyber controls.
  • Utilize risk management tools such as dFMEA to assess and mitigate potential risks in software development.

Requirements

  • Bachelor's degree in a technical field.
  • 5+ years of experience in medical device software quality assurance.
  • Mastery of ISO 14971, HIPAA, and GDPR regulations.
  • Strong proficiency in MS Office and JIRA.
  • Preferred qualifications include ASQ certifications and GHTF validation experience.

Nice to Have

  • Experience with regulatory submissions and audits.
  • Familiarity with Agile methodologies.
  • Knowledge of software development life cycle (SDLC) best practices.

What We Offer

  • Competitive salary of $150,000 per year.
  • Relocation support for your move to Minneapolis, Minnesota.
  • A collaborative and inclusive work environment that values diverse voices.
  • Opportunities for professional growth and development.
  • Flexible hybrid work setup (Monday to Thursday onsite).
Why This Job8.5 of 10

This Senior Design Assurance Engineer role offers a competitive salary and relocation support in a collaborative MedTech environment. Ideal for experienced professionals looking to make an impact.

Salary Range
Required
0/1
Optional
0/1
Bonus
0/1

Who Will Succeed Here

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In-depth knowledge of ISO 14971 and experience applying risk management principles in MedTech projects, ensuring compliance with regulatory standards throughout the product lifecycle.

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Strong analytical mindset with proficiency in DFMEA methodologies, capable of identifying potential failure modes and implementing robust design controls in a hybrid work environment.

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Proven experience with HIPAA and GDPR compliance, demonstrating a thorough understanding of data privacy regulations and their application in medical technology software and applications.

Learning Resources

→ISO 14971: Medical Devices - Application of Risk Management to Medical Devicesguide
→Design Failure Mode and Effects Analysis (DFMEA) - Overview and Best Practicesarticle
→Medical Device Risk Management - ISO 14971 Coursecourse

Career Path

Senior Design Assurance Engineer - MedTech Focus(Now)→Lead Design Assurance Engineer(1-2 years)→Director of Quality Assurance(3-5 years)

Market Overview

Market Size 2024
$15B
Annual Growth
8.5%
AI Adoption in MedTech
45%
Investment in Compliance Technologies
+25%
Labour Demand for Design Assurance Roles
+20%
Avg Salary for Senior Design Assurance Engineer
$120K

Skills & Requirements

Required
ISO 14971HIPAAGDPR
Growing in Demand
Risk Management FrameworksCybersecurity ComplianceUser Experience (UX) Design
Declining
Traditional Quality Assurance TestingPaper-Based Documentation Systems

Domain Trends

Increased Regulatory Scrutiny
With the rise of digital health technologies, regulatory bodies have increased scrutiny on compliance with ISO 14971, with 60% of companies reporting more frequent audits.
Integration of AI in Risk Management
45% of MedTech firms are adopting AI tools to enhance risk assessment processes, leading to improved compliance with ISO standards.
Shift to Agile Development Methodologies
Over 50% of MedTech companies are transitioning to Agile methodologies, which require continuous compliance checks integrated into the development lifecycle.

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