Sr R&D Engineering Manager - Infusion Disposables - R-360602

Location: United States - California - Brea

 

Job Description Summary

Research and Development Engineering is responsible for leading and mentoring a functional team to develop new and support the current commercial products by adhering to established design control processes and applying good engineering principals and documentation practices.

What is expected of you for success in your role

• Lead the technical design and development team to execute on R&D projects according to business goals


• Acquired strong working knowledge of Engineering principles and its application in solving complex technical problems with minimal guidance


• Plan and organize project deliverables according to project scope, timeline and resources


• Build, grow, and mentor a team of R&D Engineers


• Ability to set goals, direction and engage the team to achieve set goals.


• Natural collaborator. Leads through building relationships; demonstrated facilitation skills across different functions; motivated by collective success.


• Determine resource needs for new product development and existing product support. Assigns personnel as appropriate to projects.


• Extensive medical device product design and development knowledge and experience.  Adherence to established design control processes, quality systems and regulations, and good documentation practices.


• Lead cross-functional project teams to complete R&D and New Product Development/sustain engineering projects

Minimum Qualifications

• Must have a BS degree in Mechanical Engineering or Biomedical Engineering or closely related disciplines with 10-15+ yrs relevant experience


• Leadership style with excellent collaboration and communication skills


• Must have a minimum of 5 years of functional management with direct reports


• Must have strong working knowledge of Engineering principles (mechanical and materials) and strong analytical and problem-solving skills along with strong product design and development in engineering.


• Highly preferred experience with design and manufacturing of disposable products (plastics)


• Must have experienced in developing high-volume products


• Must have experienced in mechanical/materials testing and test method development experience implementing product changes through a structured, phase-gated, product development process


• Demonstrated experience in leading or supporting projects with cross-functional teams in a matrix environment


• Must have proficiency in SolidWorks or other equivalent 3D modeling software and familiarity with drawing standards


• Must have proficiency in tolerance stack-up analysis involving multiple components


• Must have understanding of fixture design including basic machining considerations, Measurement Systems Analysis (MSA)


• Must have knowledgeable in Design for Six Sigma (DFSS) and solid experience in statistical techniques


• Demonstrated ability to clearly and effectively communicate (verbal & written)


• Must have proficiency in Microsoft Project or equivalent project planning software 
  
   

Preferred Qualifications

• MS or PhD in Mechanical Engineering or Biomedical Engineering


• Experience with medical device design control preferred (high volume manufactured disposable products)


• Clear understanding of manufacturing process validation


• Good understanding of medical device product development risk management methodologies


• Experienced in using statistical analysis software (e.g. Minitab)


• Practical knowledge of intellectual property (IP)

Skills and Certifications [note: bold skills and certification are required]

plastic molding

5 + years of functional managemtn

medical device

product design, development from concept to market

SolidWorks or other 3D modeling

tolerance stack-up analysis

DFSS

MSA

MS Project or equivalent



Compensation

Base Salary - $150,000 to $180,000 *** Never repost ***

Full-time Benefits - Full

Relocation Assistance Available - Possible for ideal candidate





Candidate Details

10+ to 15 years experience

Seniority Level - Mid-Senior

Management Experience Required - Yes

Minimum Education - Bachelor's Degree

Willingness to Travel - Occasionally

Screening Questions

Do you have 10+ yrs of experience of medical device

Have you have direct reports for more than 5 years

Do you have plastic molding experience

Do you have high volume manufacturing

Do you have full life cycle product development

Do you have product conception and design experience