Welcome to an exciting opportunity to join our team as a Principal Mechanical Engineer specializing in active implantable medical devices, particularly neurostimulator devices such as IPGs, Leads, Surgical Tools, and Accessories. We are seeking a highly skilled engineer with a deep understanding of industry standards for implantable devices. In this role, you will utilize your expertise in CAD, FEA, and failure analysis to drive the design and development of cutting-edge medical devices. Additionally, your ability to present to senior leadership will be instrumental in guiding strategic decision-making. If you are passionate about pushing the boundaries of medical technology and improving patient outcomes, we invite you to be part of our innovative team.

Responsibilities:

•Take ownership of mechanical design projects related to implantable leads and IPGs.

•Lead the design, development, and optimization of implantable components, ensuring compliance with regulatory standards and performance requirements.

•Collaborate closely with cross-functional teams including R&D, electrical engineering, and manufacturing to integrate mechanical solutions into overall product development.

•Drive innovation in mechanical engineering solutions for implantable medical devices, staying abreast of industry trends and emerging technologies.

•Conceptualize and develop novel mechanical designs to enhance the performance, reliability, and manufacturability of implantable leads and IPGs.

•Provide technical leadership and mentorship to junior engineers within the mechanical engineering team.

•Guide and support the team in solving complex engineering challenges, fostering a culture of continuous learning and professional development.

•Collaborate with internal and external stakeholders to identify and address mechanical engineering issues throughout the product lifecycle.

•Work closely with regulatory affairs and quality assurance teams to ensure compliance with relevant standards and regulations.

•Prepare comprehensive design documentation, including technical specifications, engineering drawings, and test plans/reports.

•Communicate project status, progress, and technical insights effectively to key stakeholders and project teams.

•Travel ~20%. 

Qualifications:

•Bachelor’s degree in mechanical engineering or related field; advanced degree (MS/Ph.D.) preferred.

•Eight plus years of experience in mechanical engineering, with a focus on medical devices and implantable technologies. 

•Proven track record of leading mechanical design projects from concept to commercialization, preferably in a startup or fast-paced environment.

•Expertise in CAD software (e.g., SolidWorks, ProE/Creo) and proficiency in finite element analysis (FEA) tools.

•Strong understanding of materials science, manufacturing processes (machining, stamping, welding, brazing, mold design and fabrication), and design for manufacturability (DFM) principles.

•Excellent knowledge of materials used in the neurostimulation implantable such as MP35, Titanium, Platinum, Palladium, stainless steel and others. 

•Knowledge of relevant regulatory requirements and standards for medical devices (e.g., ISO 13485, FDA QSR).

•Excellent communication skills, both verbal and written, with the ability to effectively collaborate across multidisciplinary teams.

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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. 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