Sr. Manufacturing Engineer

Summary/Objective:

The Sr. Manufacturing Engineer takes a leadership role in training, developing, and educating Jr. Engineers. A strong understanding of Lean manufacturing principles and their application is required. Responsible to design, analyze, develop, and qualify manufacturing processes, materials, tooling, and fixtures to meet manufacturing needs while enhancing productivity and product quality. Critical attributes and skills include technical creativity, initiative, ability to analyze problems, prioritize and negotiate priorities, use a hands-on practical approach, multi-tasking, and coordinating between groups within the company. Performs a variety of duties that involves engineering analysis and problem solving. Works with a cross-functional team utilizing the Agile Scrum project planning process.

Primary Duties and Responsibilities

[Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualified candidates who need a reasonable accommodation with the application process and/or to perform the essential functions of the position should notify the company's HR contact]

• Support company goals and objectives, policies, and procedures, in compliance with our Quality System requirements, Good Manufacturing Practices, and FDA regulations including compliance to EN ISO 13485, Medical Device Quality Standards.
• Mentors Jr. Personnel and takes on a leadership role to accomplish tasks and achieve goals.
• Ensures that all regulatory and internal policies are followed.
• Makes decisions in a timely manner, based upon a mixture of analysis, wisdom, experience, and judgment.
• Perform root cause analysis to resolve issues.
• Coordinate multiple project activities concurrently to achieve timeline requirements; use resources effectively and efficiently while adjusting to changing priorities in a start-up environment.
• Ability to establish, build and maintain professional working relationships with all levels of staff, clients, suppliers and the public.
• Ability to work with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.
• Meticulous attention to detail and meeting deadlines.
• Demonstrates accuracy, thoroughness and monitors own and other's work to ensure quality.
• Practice and advocate good safety skills at all times.
• Special projects will require extended work hours and some travel may be required.

Required Qualifications

• Knowledge, Skills, & Abilities:
  • Ability to apply principles outlined in Quality System Regulations (QSRs/GMPs).
  • Ability to use basic hand tools such as drills, soldering irons, micrometers, calipers, etc.
  • Ability to operate electrical and mechanical equipment and interpret results.
  • Must be able to read and interpret mechanical drawings and electrical schematics.
  • Proficient with Microsoft Office and online applications.
  • Expert proficiency in Solidworks and generating CAD Drawings.
  • Ability to work well with others in a cross-functional team environment.
• Minimum Certifications/Educational Level:
  • Bachelor's Degree in Mechanical or Manufacturing Engineering.
• Minimum Experience:
  • 5-10 years of experience in a medical device environment.
  • Experience in Medical Device, or Consumer Electronics.
  • Experience in FDA/GMP/ISO environment.

Work Environment and Personal Protective Equipment

• This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners.
• Personal Protective Equipment may be required for laboratory or field work.

Physical Demands

• While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to handle or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear.
• Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
• Employee must occasionally lift and/or move up to 50 pounds.
• Wears personal protective equipment as required.
• This position is based out of Irvine, CA.
• This position requires up to five (5%) percent travel.

Location

• This position is based out of our office in Irvine, California.

Salary Range

$110,000 - $135,000

Benefits

• Comprehensive medical and dental coverage
• FSA and HSA Plan Options, including an annual company contribution to the HSA
• 401(k) program with employer match
• Generous vacation accrual and paid holiday schedule