Sr. Manufacturing Engineer

TalentBurst•Draper, UT

10d•Onsite

About The Position

Applies advanced engineering knowledge, technical leadership, and manufacturing expertise to improve and sustain manufacturing processes within a highly regulated medical device environment. This role serves as a technical leader supporting critical implantable component manufacturing operations and is responsible for driving yield improvement, capacity expansion, process robustness, and compliance excellence through structured problem solving, statistical analysis, and cross-functional collaboration. The Senior Manufacturing Engineer will lead complex manufacturing initiatives, provide technical direction to engineers and technicians, and support both existing commercial product lines as well as integration of next-generation products, equipment, and manufacturing technologies. Success in this role requires demonstrated experience delivering measurable manufacturing improvements, resolving complex technical challenges, and influencing change without direct authority. This position supports second-shift manufacturing operations and requires a high degree of independence, technical ownership, and decision-making capability in an environment with limited on-shift engineering support.

Requirements

Bachelor's Degree in Engineering or Scientific field and 4 years of industry or industry/education experience required
Master's Degree or equivalent in Engineering or Scientific field and 3 years of industry or industry/education experience required
Ph.D. or equivalent in Engineering or Scientific field with industry or industry/education experience required
Ability to manage multiple priorities and deliver results in a fast-paced manufacturing environment.
Proven ability to work independently and exercise sound engineering judgment.
Proficiency with Microsoft Office Suite, including Excel, PowerPoint, and Project.
Knowledge of applicable FDA regulations and quality system requirements.

Nice To Haves

Medical device manufacturing (or other regulated industry, FDA preferred) is highly preferred.
Metal component manufacturing is nice-to-have (Nitinol or Cobalt Chrome).
Experience in FDA-regulated manufacturing environments, preferably medical device manufacturing.
Experience with CAPA systems, nonconformance investigations, audit support, change control, and risk management processes.
Experience applying Design of Experiments (DOE), statistical process control (SPC), process capability analysis, and hypothesis testing.
Experience supporting process validation and equipment qualification activities.
Experience leading cross-functional manufacturing improvement projects with measurable business impact.
Experience supporting new product transfers, equipment implementation, or manufacturing technology integration.
Experience working with complex manufacturing equipment and automated production systems.

Responsibilities

Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.
Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
Read worker logs, product processing sheets, and specification sheets to verify that records adhere to quality assurance specifications.
Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
Observe workers using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
Evaluate data and write reports to validate or indicate deviations from existing standards.