Staff Quality Engineer

  Alameda, CA                   ·                Full time

Staff Quality Engineer

• iota Biosciences – Alameda, CA
• $135,000 – $165,000 a year

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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.

Staff Quality Engineer

We are looking for a Staff Quality Engineer who is highly motivated and passionate to engage as a quality core team member on collaborative, quality focused design and development of novel Class III active implantable devices. The Staff Quality Engineer will be expected to:

• Provide quality focused design and development by engaging with cross-functional teams to define requirements, design, verification and validation plan and strategies
• Review and approve design input/design output artifacts including requirements, design documents, code reviews, verification and validation results
• Lead and conduct risk management activities including hazard analysis and FMEAs
• Develop, modify, apply and maintain SOPs and other processes and procedures to ensure compliance to requirements and guidance
• Lead and drive CAPA (Corrective and Preventative Action) projects as required
• Drive quality improvement projects to include compliance to new or updated requirements or guidance
• Ensures that activities are complaint with policies and procedures

Qualifications:

• Bachelor’s degree in Engineering or related field
• Minimum seven years of relevant experience, or an advanced degree with a minimum of five years of relevant experience
• Technically savvy; must be able to understand and review design artifacts regarding an array of engineering disciplines and technical issues
• Organized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detail
• Effective interpersonal/communication skills

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

• Employees thrive when healthy, both physically and mentally:
• Comprehensive health coverage for you and your family, covered at 100%
• Employee Assistance Program

Time-off

• Take time off when you need to take it:
• Generous PTO policy
• Paid parental leave
• Paid holidays beyond the traditional
• Paid volunteer day

Competitive Compensation

• In addition to our competitive base salaries, we offer:
• Annual Bonus Plan
• Long Term Incentive Plan (LTIP)
• 401k plan with matching contributions equal to 100% of your deferral contributions up to 5% of your eligible compensation

Please click here to apply.