Principal Manufacturing Engineer

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• 1020 Atlantic Avenue, Suite 100 Alameda, CA 94501
• Manufacturing Engineering – Manufacturing Engineering
• Onsite

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, you will play a key role in taking company’s medical devices from engineering prototypes, through transfer to manufacturing, to production at scale. As a Principal Manufacturing Engineer, you will own manufacturing process development in various phases and execution of Class III implantable devices and external products, including: working closely with cross-functional groups and contract manufacturers’ to inform appropriate specifications, and designing, engineering & validating robust processes, both at component & system levels.

Responsibilities:

Responsibilities may include the following and other duties may be assigned:

• Initiates and completes technical activities leading to new or improved products or process, for current programs, next generation programs and to meet strategic goals and objectives of the company.  Prepares reports, publishes, and makes presentations to communicate findings.
• Thoroughly characterize manufacturing processes as part of NPI that are identified as “Critical to Quality”
• Lead manufacturing readiness design reviews
• Design, plan, and execute formal process validation activities
• Mentor and guide junior engineers from a technical perspective toward the goal of completing projects on time and with excellence.
• Manage technical partners/ vendors supporting product development and manufacturing yield and throughput activities.
• Recommend various technology options or approaches for system, processes, or program improvements in terms of safety, performance, efficiency or costs.
• Provides technical guidance and best practices for transfer from R&D to manufacturing.
• Serves as a key resource or expert in one or more of the following: technology development, product design and development, process design and development, test of materials, preparation of specifications, process study, and report preparation.
• Analyzes and solves problems from engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
• Oversee the design of test fixtures for engineering and manufacturing uses.
• Oversee the deployment and qualify electromechanical test assembly equipment.
• Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Perform failure investigation analysis with detailed root cause discovery and report results to cross-functional teams.
• Interacts cross functionally and with internal and external customers.  Serves as a consultant and subject matter expert for engineering or scientific interpretations.
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Plan and execute qualification and validation activities (TMVs, IQs, OQs, and PQs).
• Ensure processes and procedures are in compliance with regulations.

Location

iota Biosciences is based in Alameda, California.

Minimum qualifications

Please ensure the minimum requirements are evident on your resume.

• Bachelor’s degree in Mechanical, Materials, or similar related engineering disciplines.
• 8+ years of experience developing and/or manufacturing developing Class III, Active Implantable Medical Devices from concept phase to manufacturing.
• Materials expertise?
• Experience in ISO 13485 medical device manufacturing or similar regulated industry.
• Proficiency with CAD software (e.g. SolidWorks, Pro-Engineer).
• Knowledge & understanding of manufacturing processes related to implantable medical devices.
• Experience in process characterization and validation using statistical tools such as SPC, GR&R, Cp/Cpk, Design of Experiments.
• Ability to coordinate and communicate effectively with cross-functional teams.
• Experience with vendor management.
• Up to 25% travel may be required.

Preferred qualifications

• Strong willingness to be hands on and support a wide variety of activities.
• Experience manufacturing active implantable medical devices.
• Established experience working in both early-stage technology and R&D projects.
• Understanding and application of Geometric Dimensioning & Tolerancing (GD&T).
• Strong desire to be hands on and support a wide variety of activities.
• Portfolio of complex engineering challenges with high degree of ownership.
• Experience with the design, assembly and test of electro-mechanical assemblies.
• Self-motivated to seek out new ways to solve problems.
• Six Sigma Green Belt or equivalent certifications.
• Support pFMEA creation and maintenance throughout product life cycle

Salary Range : 170000 – 190000 USD / year

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