Sr. Manufacturing Technician, NPI

Sr. Manufacturing Technician, NPI

Hayward, CA - Onsite

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.

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.

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 communication skills.
• Ability to establish and maintain good working relationships with all functional areas.
• Experience in a fast-paced start up environment.
• Ability to work conscientiously and with minimal direction, using good judgement, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to lift 10-15 pounds.

Pay Range: Compensation is determined based on a wide range of factors including location, 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: $30.00 per hour - $45.00 per hour. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.

Ready to Shape the Future of Healthcare?