Staff Design Verification Engineer

Quality – Quality           ·            1020 Atlantic Avenue, Suite 100 Alameda, Ca 94501 (Hybrid)              ·            Full time

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.

We are looking for a Staff Design Verification Engineer who is highly motivated and passionate to engage as a design verification team member owning design verification activities for novel Class III active implantable devices. The Staff Design Verification Engineer is expected to:

• Ensure allocation of appropriate verification methodology to design requirements, including testing, inspection, simulation, and analysis
• Develop design verification plans and protocols to effectively demonstrate design inputs and regulatory requirements using effective design verification test strategies
• Apply a risk-based approach to sample sizes and test methodologies for both attribute and variables testing
• Plan and coordinate verification execution internally or with third-party suppliers
• Analyze data and document verification evidence in reports, as well as maintain verification traces for each platform solution
• 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
• Support design verification lab maintenance including equipment calibration and preventative maintenance, inventory, and safety measures
• 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

Key Qualifications

• Bachelor’s degree in Biomedical, Mechanical, Electrical, or Chemical Engineering, or related disciplines
• Minimum seven years of relevant experience
• Experience with standards and test methods for medical devices, e.g. electrical safety, mechanical, aging, biocompatibility, sterility, and/or packaging
• Strong technical writing and documentation review skills; high attention to detail 
• Technically savvy; must be able to understand and review design artifacts across an array of engineering disciplines and technical issues
• Organized, self-motivated, demonstrated ability to effectively manage multiple projects and priorities
• Demonstrated experience with root cause analysis
• Effective interpersonal/communication skills

Preferred Qualifications

• Minimum five years’ experience in a regulated industry, preferably medical devices
• Previous experience in R&D
• Experience with active implantable medical device related standards, e.g., ISO 14708, IEC 60601
• Demonstrated understanding of DOE (design of experiments) and MSA (measurement system analysis, including test method validation), and associated statistical analyses
• Experience developing custom test methods that mimic biological environments, use cases, and use environments
• Experience with MCAD, ECAD, test software (e.g. LabView, Python scripting)
• Experience with statistical software (e.g. JMP, Minitab)
• Experience with stochastic modeling software (e.g. Reliasoft RENO, Crystal Ball

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:

• 100% employer-paid Anthem Platinum PPO or Kaiser Platinum plans, as well as dental, and vision, for employees and dependents at 100%
• Short-Term and Long-Term Disability
• Employee Assistance Program
• 401k plan – matching contributions equal to 100% of your deferral contributions up to 5% of your eligible compensation
• Bonus Plan
• Long Term Incentive Plan (LTIP)
• Four weeks of vacation, two floating holidays, and nine company paid holidays

Please click here to apply.