Manufacturing Engineer

Mach Medical, in partnership with Sites Medical, seeks to revolutionize the orthopedic supply chain by creating a contract manufacturing operation capable of building the highest quality joint replacement implants off a patient’s pre-operative surgical plan and supplying that product in time for their surgery.
Team members will leverage their grit and curiosity-fueled problem solving talents to deploy Mach’s proprietary high velocity manufacturing that delivers game-changing reductions in OEM inventory, build a career platform that enables them to do the best work of their career, and amplify the energy level of a team that is mission focused.
*Job Description* The successful candidate will have a command of translating customers’ product requirements into a world class manufacturing operation for orthopedic implants, developing and deploying highly stable and validated processes, and driving improvements through lean six sigma problem solving techniques.
State-of-the-art manufacturing technologies will be developed and implemented on a foundation of lean manufacturing principles and in compliance with 21 CFR Part 820 and ISO 13485:2016 quality management systems.
Candidate thrives in a startup environment where collaboration is vital, resourcefulness is essential, and expanding personal expertise is embraced.
*Essential Duties and Responsibilities* · Lead intercompany cross-functional teams in the transfer of customer requirements to highly repeatable and efficient factory operations that support a high-mix, low-volume product flow.
· Lead cross-functional team in the development of all relevant device master record components.
· Design, develop, and deploy state of the art medical implant manufacturing processes including machining, metal finishing, inspection, cleaning, biological upgrade and clean room packaging operations.
· Collaborate with essential team members to optimize factory workspace for product and information flows.
· Research, select, and deploy factory equipment essential to state-of-the-art manufacturing.
· Research, select, and deploy factory automation, robotics, and advanced software applications that drive factory efficiencies, predictability, and repeatability.
· Execute all stages of process validation: author statistically driven, risk-based protocols, equipment installation and qualifications, operational qualifications, challenge tests, process qualifications, and measurement reliability and repeatability studies.
· Meticulously document processes, procedures, and work instructions.
Effectively train users on those process elements.
· Improve established processes utilizing lean and or six sigma problem solving techniques.
· Other duties as assigned.
*Education and Experience* · Minimum of BS degree in Engineering, Technology, or equivalent experience is required: Mechanical, Manufacturing, Industrial, or Material Science.
· 5 or more years of manufacturing engineering experience in a highly regulated environment.
(Experience level will dictate the amount of autonomy the employee has.
) · Lean, and or six sigma certifications are preferred.
*Knowledge, Skills, & Abilities* · Expert in state-of-the-art medical implant manufacturing · Expert in 21 CFR Part 820 and working knowledge of 21 CFR Part 11 and ISO 13485, ISO 14971, and Global Harmonization Task Force on Process Validation Guidance document.
· Mastered geometric dimensioning and tolerancing, as well as general blueprint reading.
· Mature skills in project management, Lean manufacturing, and six sigma problem solving.
· Proficient with Microsoft Office applications, contemporary CAD/CAM systems, and ERP systems.
Familiarity with eQMS and PLMs desired.
· Effectively communicates using verbal and written media.
Accurately and completely captures information and reflects in company records.
· Resourcefully and frugally adapts to workload requirements.
*Environmental & Physical Demands* · Work is conducted in an office and manufacturing environment.
· Work hours will periodically fluctuate to support a factory that operates 24 hours per day and 7 days per week.
· Remote work will be accommodated as practical.
· May require long periods of time in front of a computer.
· Will be exposed to factory chemicals that include machining lubricants, cleaning detergents, and biological upgrade solutions, as well as metallic powders and dusts.
_*Note:*_ _Mach Medical is a small, hardworking, family-oriented company where everyone helps no matter the task.
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
_ Job Type: Full-time Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Flexible schedule * Health insurance * Health savings account * Life insurance * Paid time off * Parental leave * Tuition reimbursement * Vision insurance Schedule: * Day shift * Monday to Friday Work Location: In person