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Posted: Wednesday Sep 12, 15:01 PDT Updated: Wednesday Sep 12, 15:11 PDT

Sr Sustaining Engineer Job Code: N07247D

Boulder

Job Code: N07247D
Salary Information: $70K-$95K
Job Description:
Sr Sustaining Engineer

SUMMARY OF POSITION:

Engineer responsible for identification and resolution to problems
associated with currently manufactured products and with products and
processes currently under development. Engineer will lead projects and
efforts to minimize impact on business goals, including quality,
performance and back order. Activities involve working in a team
environment with members from the manufacturing sites, marketing, R&D,
quality, regulatory or other departments with special emphasis on CAPA
resolutions.

ESSENTIAL FUNCTIONS:

1. Work to maintain product performance and quality by leading and
assisting with issues relating to CAPAs, complaints and manufacturing
support, such as:
• Failure investigation and analysis
• CAPA resolution
• Regulatory compliance
• Product and process validation
• Performance verification
• Design changes
• Test method and tooling design
• Process enhancement and improvement
2. Identifies trends in problems and issue with product (from
manufacturing sites or from the field/service) and acts to resolve issues
with long term application of solutions and preventative measures.
3. Identifies immediate solutions for short term corrections to prevent
impact to business goals.
4. Works to integrate product performance activities with new product
development to improve delivery time and reduce post release production
issues.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
1. Prepare analysis reports for director(s), project leaders or other
personnel.
2. Present project status to management and teams, as required.
3. Develop and track work schedule and assignments.
4. Provide input to departmental planning and resource activities.

Requirements MINIMUM REQUIREMENTS: Education: * BSEE or equivalent and
experience in electronic engineering processes and product life cycles.
Experience: * 7+ years in medical device design or manufacturing industry
with 5+ years in manufacturing engineering / support Preferred
Skills/Qualifications: •Experience with analog and digital
design •Experience with OrCad, PSpice •Experience with regulatory audits
and compliance activities •Experience with documentation activities,
report writing, test method development, product qualification, validation
activities and manufacturing process support. •Excellent communication
skills, verbal and written Preferred Skills and
Qualifications: •Familiarization with Design for Six Sigma •Experience
with MiniTab mathematical analysis software •Experience with AutoCad (or
similar drafting software) Skills/Competencies: Other
Skills: •Familiarization with Agile documentation database system

Reply to: kim_hiremagic@yahoo.com
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