Manager, Manufacturing

Location
Hayward, CA, United States
Posted
May 29, 2021
Ref
1063
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.

We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. We take pride in hiring the best and brightest minds to our world-class company. Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture.
Position Summary:

Hands-on, experienced manufacturing manager with drive, ambition and desire to own and execute all aspects of production and product support/servicing to achieve world-class results. Responsible for production of durable products and provide support for single-use products.
Essential Duties and Responsibilities:
  • Drive manufacturing and work closely with Manufacturing Engineering, Materials, R&D and Quality to effectively transition products to manufacturing. Key representative and contributor in project development team.
  • Own overall responsibility for all in-house manufacturing operations, including production planning, product assembly, product test and troubleshoot, manufacturing and product field support.
  • Based on forecast demand, establish and maintain production schedules and monitor daily/weekly. Monitor and initiate quick resolution on NCMR’s.
  • Collaborate with Manufacturing Engineering on operations processes, including hands-on definition of MPIs, WI’s, TPs, DHRs, etc. and into review and approval of ECO’s.
  • Must be hands-on in executing day-to-day tasks as well as strategic, able to develop world-class operations.
  • Hire, train, and supervise manufacturing staff.
  • Define operations initiatives, apply analytical and statistical methods to continually improve quality, reduce cost, reduce cycle time and simplify processes using proven manufacturing practices/principles (Lean Manufacturing, etc.). Develop and implement manufacturing metrics.
  • Ensure compliance with company policies, procedures, and regulatory.
  • May lead or support failure investigations. Collaborate cross-functionally to achieve quick resolution on product complaints per established SOP’s on Complaint Handling and CAPA.
  • Collaborate cross-functionally to define product servicing strategy and infrastructure.
  • Responsible for operational facilities expansion & facilities maintenance.
  • May perform other duties as assigned.
Education and Experience:
  • Bachelor's degree in business management, engineering, manufacturing, industrial engineering, or a related discipline required.
  • A minimum of 7 years' experience in one or more disciplines of manufacturing operations (e.g., manufacturing, assembly & test, manufacturing engineering, subcontract, service).
  • At least 5 years in a direct-line managerial position of teams that perform manufacturing, manufacturing engineering and/or operational execution functions.
  • 3 to 4 years’ experience in medical device industry required.

Skills, Abilities, and Other Requirements:
  • Technical knowledge of assembly and test of electronic equipment.
  • Excellent knowledge of ERP systems, quality assurance and lean manufacturing.
  • Proven team leadership and excellent communication skills; written, verbal and presentation.
  • Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other national and international regulations and standards.
  • SolidWorks, Adobe Acrobat Professional, Adobe Illustrator, Zebra Printer hardware/software.
  • Proficient knowledge and skill in Microsoft Office Suite applications.
  • Excellent oral written communication skills and critical thinking skills.
  • Ability to travel up to 10% of the time. Overnight and/or international travel may be required.
  • Ability to lift 10-15 pounds.


Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at www.pulsebiosciences.com.

At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce. 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.

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.