Senior Manufacturing Engineer

Cynet Systems•Draper, UT

2d•Onsite

About The Position

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. 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.

Requirements

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.
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.

Nice To Haves

Initial focus on sustaining activities for an established product line.
Project responsibilities are expected to be limited initially.
Technical ownership of CAPA investigations is not expected during this six-month assignment.
Protocol development or new equipment and product work may arise, but is not the primary initial focus.

Responsibilities

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.
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.
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.
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.