Anteris Technologies
Senior Design Assurance Quality Engineer
Brooklyn Park, MN · Senior
No sponsorship$110k-$130kDetected 21 days ago
Product ManagementProcess ImprovementFDA RegulatoryMedical DevicesCommunicationProblem SolvingRegulatory Affairs
About the role
- With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
- Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function.
Nice to have
- Review V&V protocols, test data, and ensure that all verification and validation activities are appropriately documented.
- Prepare and present project status updates, risk assessments, and quality reports to senior management.
- Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
- Advanced degree preferred.
- Experience with regulatory standards such as ISO 13485, 14971, and FDA 21 CFR Part 820
- Excellent problem-solving skills and attention to detail.
- Strong communication and interpersonal skills.
- Certification in quality engineering (e.g., CQE, CQA) is a plus
Skills
- Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care.
Compensation
- Target base salary range: $110,000 - $130,000, plus eligibility for an annual short-term incentive (STI) targeted at 8.5% of base salary and equity participation.
- Final compensation will be determined based on experience and alignment with role requirements.
- Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.
- $110,000 - $130,000 USD
- Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.
- What We Offer:
Benefits
- Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
- Competitive compensation package, including salary, performance-based bonuses, and stock options.
- Our Health and Wellness Offerings:
- Medical, Dental, and Vision Offerings
- Flexible Spending Account (FSA)
- Life, AD&D, Short Term and Long-Term Disability Insurance
- Bonus Plan Eligibility
- Employee Equity Program
Company info
- Career development opportunities and a chance to be part of a growing company that values its employees.
Visa & Work Authorization
- Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.
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