Job description

Job description

The successful candidate will be responsible for supporting our existing products through design and manufacturing improvements, process analysis, validation and verification of new components, writing production procedures, investigation of field failures, writing technical documents, working with vendors to improve quality, and documentation of changes in accordance with regulatory agencies.

Minimum Qualifications:

• Bachelor of Science degree (B. S.) in Manufacturing Engineering or equivalent from a four-year college or university.
• Ability to read and develop drawings.
• Solidworks or similar CAD experience desired.
• Experience with process improvements including tact time analysis.
• Experience with writing and performing IQ/OQ/PQ and Validations.
• Experience with the CAPA process.
• Experience with writing assembly instructions and other production documents.
• Experience with writing and completion of Engineering change orders.
• Knowledge of injection molding.
• Problem-solving abilities.
• Attention to detail.
• Strong organizational and communication skills.
• Analytic, creative, and business focused problem solver.
• Experience working within a formal Quality Management System.
• The ability to multitask.
• Excellent written and verbal communication skills.
• Team Player who is interested in a long-term commitment.

Required Skills

• IQ/OQ/PQ
• Validations
• Manufacturing Time studies
• CAPA - Corrective Action Preventative Action

Job Responsibilities

• Designing, implementing, maintaining, and improving manufacturing fixtures, jigs, and Medical Device products.
• Writing Validation and Verification protocols pertaining to products, fixtures, manufacturing processes and fixture maintenance.
• Responsible for released technical writing, assembly drawings, assembly instructions, engineering change orders, manuals, and test evaluations.
• Analyzing current processes by performing tact time analysis for improved efficiency.
• Implementation of automated processes for improved efficiency.
• Troubleshooting and optimization of in-house production equipment.
• Work with outside vendors to ensure all designs can be manufactured to specifications at a reasonable cost, timely manner and meet incoming inspection quality standards as required per FDA GMPs and Bunnell, Inc.
• Write First Article Inspection records for product components and assemblies.
• Collaborate Quality Assurance in assuring all assembly and process instructions are current.
• Initiate Engineering Change Orders and assist Document Control Technicians within the ECO process. Participates in the review and sign off of Engineering Change orders.
• Participate in the Non-conforming Material Review Board for product component and assembly rejects.
• Observe all company safety policies and practices.
• Maintain and encourage cooperative relationships with all other Bunnell employees in supporting the company mission and strategic plan.

Schedule:

• 8:00 a.m. - 4:30 p.m.

Education:

• Bachelor's in Manufacturing or Mechanical Engineering

Work Location: One location

Job Type: Full-time

Pay: From $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Experience level:

• 2 years
• 3 years

Schedule:

• 8 hour shift

Work setting:

• In-person
• Manufacturing facility

Ability to commute/relocate:

• Salt Lake City, UT 84115: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Manufacturing: 2 years (Required)

Work Location: In person

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