Ultimate
Manufacturing Lead
At a glance
Location: US-CA-San Juan Capistrano Map
Posted: 10/01/2020
Closing: 10/31/2020
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
Ultimate
Job description
Privately held, early growth stage medical device company that is currently in development of minimally invasive medical devices to treat peripheral and coronary arterial disease seeking a Manufacturing Lead to come aboard full time. 
Essential Job Responsibilities
  • Create and maintain accurate documentation in coordination with the Quality Assurance and Manufacturing functions.
  • Support development and implementation of new processes, equipment and products.
  • Initiate and coordinate work with outside vendors and internal personnel.
  • Lead prototype and pilot production efforts of new products, product changes, and enhancements in coordination with the Engineering and Quality Control functions.
  • Complete accurate and timely preventive maintenance of equipment and tooling.
  • GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions
  • Complies with established Company and departmental policies and procedures, objectives, quality assurance program, safety and environmental standards.
  • Support to resolve issues such as non-conforming materials (NCMRs) and Corrective and Preventative Actions (CAPAs). 
  • Support the Engineering in projects by calculating production, labor, and material costs, collecting timing studies, and estimating future requirements.
  • Ability to read and interpret engineering drawings. 
  • Other duties as assigned as an emerging growth company it may be required from time to time to assist in other areas other than the area of specialty.

Required Skills, Abilities & Technical Knowledge
  • GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
  • Ensure that all regulatory and internal policies are followed
  • Makes good decisions in a timely manner, based upon a mixture of analysis, wisdom, experience and judgment. 
  • Resolves issues and overcomes obstacles to assure successful events.  Uses independent judgment to resolve unique challenges that arise with each event.
  • Orchestrates multiple activities at once to accomplish a goal; uses resources effectively and efficiently; can adjust in light of change and shifts gears comfortably.
  • Is very productive and efficient in planning and executing role responsibilities.
  • Pursues everything with energy, drive and a need to finish; seldom gives up, even in the face of resistance or setbacks; steadfastly pushes self and others for results.
  • Good at determining the processes necessary to get things done; knows how to organize people and activities; can simplify complex processes.
  • Ability to establish, build and maintain professional working relationships with all levels of staff, suppliers and the public.
  • Ability to work with minimal supervision.
  • Excellent interpersonal, verbal and written communication skills.  Meticulous attention to detail and meeting deadlines.
  • Quality control, i.e., demonstrates accuracy and thoroughness and monitors own work to ensure quality.
  • Special projects will require extended work hours and some travel may be required.
Education & Experience
  • High School Diploma with related industry experience preferred.
  • Working knowledge of inspection tools such as: calipers, micrometers, snap gage, microscope, tensile tester, VIS and pin gages.
  • Product testing experience
  • Prototype design and building experience
  • Experience with medical device manufacturing processes qualifications (IQ/OQ/PQ)
  • Intermediate level skill in Microsoft Word, Excel, Outlook and other office software programs.
Environmental Conditions
  • Works in a Lab/Clean Room environment, within a well-lighted work area with good ventilation and normal noise levels from lab/shop equipment/Clean Room.
  • Frequent standing and/or walking; occasionally sit at desk and intermittently answer the telephone and write or use a keyboard to communicate through written means.
  • Some lifting up to 20 lbs. may be required.


 

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
Manufacturing Lead