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Sr. Manufacturing Technician, NPI

External
pulsebiosciences logoPulsebiosciences · Hayward, CA
Full-timeOn-site2d ago
AssemblyComplianceDocumentationExcelPrototyping
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About the role

The Sr. Manufacturing Technician, New Product Introduction (NPI) will be responsible for performing, transferring, and training manufacturing operations, including the assembly and testing of disposable products. The role will collaborate with cross-functional teams in R&D, Quality and Operations to ensure manufacturing processes are established, documented and executed in accordance with regulatory requirements. To Make an Impact, You Will: Perform manufacturing operations using documentation as released within the Quality Management System (QMS) in compliance with cGMP. Assist Engineering with prototype build to effectively transition product cycle from Development to NPI to Manufacturing. Assist in new product transfer of manufacturing to contract manufacturer including training of staff. Train and assist manufacturing personnel at contract manufacturing facility Contribute in hands-on definition of MPIs, WIs, TPs and DHRs. Identify and support ECO changes required and work with manufacturing engineering for its implementation. Provide support in manufacturing products for animal lab studies including execution of design verification and validation activities. Provide assistance in materials logistics and quality such as receiving, receiving inspection, stocking and kitting of work orders for in-house or outside manufacturing. Perform activities required to process RMA's and administrative field returns. Contribute to operations initiatives to continually improve quality, reduce cost, reduce cycle time and simplify processes. Assist in future facilities expansion activities & facilities maintenance. Ensure compliance with company policies, procedures, and regulatory. To Excel, You Will Bring: High School diploma or equivalent required. Minimum 5+ years of hands-on experience with prototyping, NPI or direct manufacturing in a medical device environment. Catheter development and production experience required. Experience soldering small components under a microscope preferred. Some technical knowledge of assembly and test of electronic equipment including software application/program preferred. Proficient knowledge and skill in Microsoft Office Suite applications. Excellent oral and written communication skills with critical thinking skills. Understands cGMP & ISO job related regulations. Highly organized, detailed oriented, and the ability to be flexible taking on many different tasks. Strong analytical, interpersonal and

Benefits

Health insurance401(k)Flexible scheduleEquity / stock options

Additional Information

Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine Pulse Biosciences 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 CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more. Why Join Us? At Pulse Biosciences, we are driven by purpose and innovation. Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration. Our Commitment: Hiring the best and brightest minds to advance our world-class organization. What You Will Experience: Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together! Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly! Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment! Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan. Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success. Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes. Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce.


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