Staff Design Verification Engineer
400 Wind River Way Alameda, CA 94501
Quality – Quality /
Hybrid /
Hybrid
We are looking for a Staff Design Verification Engineer who will leverage their advanced wide-ranging experience in development of active implantable medical devices to engage as a verification project lead and subject matter expert with the project core team. This person must be highly motivated, dedicated, and committed, willing to put in the effort and work required at this level, which will include working outside of normal business hours and being flexible but persevering in a fast-paced development environment. The Staff Design Verification Engineer will serve in the Quality Assurance organization in a strong technical capacity. They will be expected to be at the forefront of completing the entire verification strategy for the implantable and external portions of a medical system. They will also be expected to converse technically with the engineering organization.
Responsibilities
- Write and review design verification plans and protocols to effectively demonstrate design inputs and regulatory requirements using the effective design verification test strategies
- Ensure allocation of appropriate verificationmethodology to design requirements, including testing, inspection, simulation, and analysis
- Apply a risk-based approach to sample sieces and test methodologies for both attribute and variables testing
- Plan and coordinate verification execution internally with junior engineers and technicians
- Actively manage and engage with relevant third-party test vendors, holding them accountable to results and ensuring their test methods are executed appropriately
- Analyze data and document verification evidence in reports, as well as maintain verification traces for the platform
- Develop test methods through use of CAD tools and test software, procure and qualify test equipment, design and/or coordinate development of test fixtures with engineering teams
- Perform test method validation on new and existing test methods
- Collaborate with engineering teams to develop and characterize active implantable medical device designs from a design verification perspective for designs spanning across multiple products and technologies including mechanical and electrical assemblies, embedded firmware, and software applications
- Support and potentially drive multiple root cause analysis activities
- Drive quality improvement projects to include compliance to new or updated standards, requirements, or guidance
- Ensure activities are compliant with policies and procedures
- Other roles as assigned
Key Qualifications
- Bachelor's degree in Biomedical, Mechanical, Electrical, or Chemical Engineering, or related disciplines
- Minimum eight plus years of relevant experience in the medical device field, or an advanced degree with a minimum of six years of relevant experience in the medical device field
- Must have experience being involved in pre-market submission activities for Active Implantable Medical Devices to be considered for this role
- Demonstrated autonomy and accountability
- Extensive knowledge of standards and test methods for medical devices, eg electrical safety, mechanical, aging, biocompatibility, sterilization, and packaging, particularly ISO 14708, ISO 60601, ISO 10993, ISO 14791
- Strong technical writing and document review skills
- Demonstrated complex problem solving and root cause analysis skills
- Organized, self-motivated, with a growth mindset
- Strong collaborator across all functions of the organization, particularly engineering, maintaining an open mind and flexibility in project focus as issues come up
- Strong demonstrated influencing skills
$160,000 - $180,000 a year
iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics. Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.
iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families. iota’s core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases. At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic. At iota Biosciences, we take pride in providing equal employment opportunities to everyone, inclusive of race, ethnicity, beliefs, religion, marital status, gender, gender identity, citizenship status, age, veteran status or disability.
iota offers a very competitive benefits package that includes the following:
Health & Wellness
Comprehensive health coverage for you and your family, covered at 100%
Access to quality dental and vision
Onsite Gym in Alameda
Work-Life Balance
Generous vacation pay
Paid parental leave
Options for flexible work schedules
Competitive Compensation
Annual Bonus Plan
Long Term Incentive Plan (LTIP)
401k plan with employer match
