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Senior Manufacturing Engineer - Hayward, United States - Pulse Biosciences, Inc.
Description
Pulse Biosciences(Nasdaq:
PLSE) is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.
The Company's proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue.
The Company is actively pursuing the development of its nsPFA technology for use in electrophysiology and the treatment of atrial fibrillation.
Visit to learn more.At Pulse, we:
Exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
Are individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude that will excel in our culture.
About the Role
As a Senior Manufacturing Engineer, you will be responsible for manufacturing engineering, production, product support, and servicing to achieve world-class results for both durable and disposable products.
Driving manufacturing engineering and working closely with R&D and Quality to effectively transition products to manufacturing, serving as a key representative and contributor on a project development team.
Championing New Product Introduction (NPI) activities and actively mentoring and supporting the development team to ensure company objectives are met.
Lead capital, durable, and disposable product transfers through to low-volume and high-volume production.Leading operations processes definitions, including hands-on specification of MPIs, TPs, DHRs, etc.
Conducting PFMEA analyses; defining and executing process validations.
Working with external vendors including contract manufacturers.
Contributing to operations initiatives, applying analytical and statistical methods to continually improve quality, reduce cost, reduce cycle time and simplify processes.
Reviewing and interpreting engineering drawings, technical reports (tolerance stack analysis, technical justifications, etc.).Providing SME guidance to Engineering for product manufacturability and design transfer.
Providing technical expertise and mentoring to other engineers and technicians on the team.
To be successful, you will bring:
Bachelor's degree in engineering, manufacturing, industrial engineering, or a related discipline required.
5+ years' experience in one or more disciplines of manufacturing operations (e.g., manufacturing, assembly and test, manufacturing engineering, subcontract, service) with a minimum of 3 years of experience in the Life Science or Medical Device industry.
Tooling and fixture design background desired.Technical knowledge of assembly and test disposable and/or capital equipment.
Working knowledge of manufacturing engineering, ERP and PLM systems, quality assurance and lean manufacturing processes.
Must be able/willing to travel to Contract Manufacturers for process development, training, etc.
Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other national and international regulations and standards.
Experience at start-up companies preferred.
Controlled environment room (CER) experience desired.
SolidWorks, MiniTab, Zebra Printer hardware/software.
Proficient knowledge and skill in Microsoft Office Suite applications (Word, Excel, Project, PowerPoint, Visio).
Excellent oral, written, and presentation communication skills and critical thinking skills.
Ability to lead team activities and provide SME guidance to resources inside and outside of operations.
Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.
Ability to travel up to 15% of the time. Overnight and/or international travel may be required.Ability to lift 10-15 pounds.
You'll experience:
Purposeful and rewarding work collaborating with bright and curious minds
Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment
A variety of health insurance plans and supplemental insurance options.
401k retirement savings plan.
Stock options awards and ESPP program.
Paid time off, paid holidays, and flexible work schedule.
Wellness program with free onsite gym, mindfulness classes and activities.
A commitment to providing a respectful work environment to our diverse workforce.
Pay Range:
Compensation is determined based on a wide range of factors including job-related skills, experience, education, and training.
It is not typical for an individual to be hired at or near the top of the range for their role.
This pay range is specific to Northern California location.Base salary range:
$125K - $140K
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law.
Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at
LOCAL CANDIDATES ONLY
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.
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