Sr. Manufacturing Technician, NPI

Pulsebiosciences; Hayward (CA); On-site; USD 41,328 - 61,992; Full time

Benefits offered by this job

Health insurance

Stock options

Flexible work schedule

Job summary

Pulsebiosciences in Hayward, CA is looking for a Sr. Manufacturing Technician to handle new product introduction and support manufacturing operations. You will perform critical tasks pertinent to the assembly and testing of medical devices, ensuring compliance with regulatory standards.

The ideal candidate has over 5 years of relevant experience, particularly in catheter production, and possesses strong communication skills. This position offers a competitive hourly wage with comprehensive health benefits.

Qualifications

• Minimum 5+ years experience in a medical device environment.
• Experience in catheter development and production.
• Ability to lift 10-15 pounds.

Responsibilities

• Perform manufacturing operations in compliance with cGMP.
• Assist Engineering with prototype builds.
• Train contract manufacturing staff.

Skills

Prototyping experience

NPI experience

Medical device manufacturing

Soldering small components

Microsoft Office proficiency

cGMP and ISO understanding

Strong communication skills

Education

High School diploma or equivalent

Job description

Company Overview

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.

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, detail‑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.

Benefits

• Comprehensive benefits including 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 – 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.

Pay Range

Compensation is determined based on a wide range of factors including location, job‑related skills, experience, education, and training. This pay range is specific to the 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.

Equal Employment Opportunity

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. We will make reasonable accommodations for qualified individuals with disabilities.