Position Title: Sr. Engineer Work Location: Draper, UT 84020 Assignment Duration: 6 Months Work Schedule: Monday through Thursday, 3:30 PM to 2:00 AM the following day, Draper local time. Four 10-hour shifts with a 30-minute lunch. Work Arrangement: Onsite
Position Summary:
The Senior Manufacturing Engineer sustains and improves manufacturing processes for implantable metal components in a regulated medical device environment.
The initial focus is ownership of sustaining activities for an established product line, including daily production support, troubleshooting, and continuous improvement.
Background & Context:
This role provides on-site support for second-shift manufacturing operations.
Success requires strong manufacturing judgment, the ability to learn technical processes quickly, and independent decision-making with limited on-shift engineering and management support.
The engineer works closely with first-shift engineers and Operations to maintain continuity and address production needs.
Project responsibilities are expected to be limited initially and may develop as the engineer becomes familiar with the line.
Key Responsibilities: Production Support and Process Improvement
Coordinate with first-shift engineers at the start of the shift to review open issues, completed work, and priorities.
Participate in Operations standups and shift handoffs.
Work directly with operators and equipment to investigate scrap, process variability, equipment downtime, and other production issues.
Apply structured problem solving, root cause analysis, Lean or Six Sigma methods, and statistical analysis to improve yield, equipment uptime, throughput, and process capability.
Learn the product line, equipment, and material behavior; identify process pain points and implement measurable improvements with Operations, Quality, Maintenance, and other partners.
Validation and Technical Documentation
Execute established validation and qualification protocols, analyze results, and prepare clear technical reports for core-team review and approval.
Support engineering studies and process or equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), as assigned.
Maintain manufacturing documentation, work instructions, procedures, and engineering records. Protocol development or new equipment and product work may arise, but is not the primary initial focus.
Technical Collaboration and Quality Support
Provide technical direction and training to engineers, technicians, and Operations personnel; influence improvements across teams without direct authority.
Support manufacturing investigations, nonconformances, process deviations, audit activities, and corrective or preventive actions as needed. Technical ownership of CAPA investigations is not expected during this six-month assignment.
Support assigned improvement projects and assess process or equipment changes for safety, quality, performance, and regulatory requirements.
Perform other incidental duties as assigned by leadership.
Qualification & Experience: One of the following education and experience combinations is required:
Bachelor's degree in Engineering or a scientific field and four years of industry experience or combined industry and education experience.
Master's degree or equivalent in Engineering or a scientific field and three years of industry experience or combined industry and education experience.
Ph.D. or equivalent in Engineering or a scientific field, with industry experience or combined industry and education experience.
Required Skills and Capabilities
Ability to work independently, exercise sound engineering judgment, and manage multiple priorities in a fast-paced manufacturing environment.
Ability to quickly learn technical manufacturing systems and communicate effectively during shift handoffs and work with operators, engineers, and other teams.
Data analysis and technical writing skills sufficient to interpret study results and prepare technical reports.
Proficiency with Microsoft Office, including Excel, PowerPoint, and Project.
Knowledge of relevant FDA regulations and quality system requirements.
Preferred Experience and Screening Priorities
Strong evidence of structured problem solving and root cause analysis, including Lean or Six Sigma methods.
Documented manufacturing improvements, such as reduced scrap, increased equipment uptime, or improved throughput.
Process validation or equipment qualification experience, including IQ, OQ, and PQ.
Experience in regulated manufacturing, especially FDA-regulated medical device manufacturing, is strongly preferred.
Candidates from other industries may be considered; those without regulated experience should demonstrate deeper manufacturing experience and the ability to learn regulatory requirements.
Metal component manufacturing experience, including nitinol or cobalt-chromium, is a plus.
Experience with complex equipment, automated production systems, Design of Experiments (DOE), statistical process control (SPC), process capability analysis, or hypothesis testing.
Experience with CAPA systems, nonconformance investigations, audits, change control, risk management, manufacturing improvement projects, product transfers, or equipment implementation.
Regulated manufacturing experience is strongly preferred, especially FDA-regulated medical device experience. Other industries may be considered.
Candidates without regulated experience should demonstrate more extensive manufacturing experience; no additional fixed years requirement was established.
Metals experience is a plus.
Candidates with strong medical device quality or validation backgrounds and less hands-on manufacturing experience may also be considered individually.
The initial assignment emphasizes sustaining support.
Validation activities will generally use existing protocols, with analysis and reporting required.
Extensive project ownership, new product or equipment introduction, and CAPA investigation ownership are not expected as the initial focus.
Local candidates will receive priority, followed by nonlocal candidates who can relocate at their own expense.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $53.00/hr - $55.88/hr.
