We are hiring a Contract (possible contract to permanent) Technical Program Manager (up to Senior level) to drive high-quality and timely execution of the company projects. You will support the implementation of strategic decisions and product direction changes per the evolving project objectives. You will lead projects and provide oversight over the scope, budget and schedule of the company projects as well as supporting resource allocation decisions. This is a hybrid role with three days a week required on-site at the Iota facility in Alameda, CA (not a remote role).
Responsibilities:
•Develop a working knowledge of technical program details
•Build program and project schedules to deliver against set timelines
•Organize and lead regular interdisciplinary team meetings to drive progress towards goals and review action items
•Maintain schedules and keep plans up-to-date through collaboration with cross-functional teams
•Proactively identify and communicate program risks and drive mitigation measures
•Ensure Design Control processes are followed per relevant procedures
•Serve as point of contact for communication on project status, critical path, and program risks
•Orchestrate the construction of the Design History File documentation that will be needed for FDA submission in coordination with Quality and Regulatory functions
Qualifications:
•Minimum of two years' experience in technical program management, with a minimum of two years' experience leading new medical device development projects in an ISO13485 regulated environment (while following procedures based on FDA design controls regulations)
•Bachelor's degree in relevant technical field (such as engineering or physics)
•Excellent organizational and communication skills, detail oriented
•Ability to work with cross-functional teams and manage multiple projects simultaneously
•Familiarity with fast-paced environments and ability to manage ambiguity
•Ability to influence and motivate all levels of an organization
•Preferred: In depth experience executing and managing the Design Verification phase
•Preferred: In depth experience with Software Testing (IEC 62304, FDA guidance)
$135,000 - $170,000 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