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Production Manager

MEVION MEDICAL SYSTEMS INC

Littleton, MA Job Details Full-time $130,000 - $145,000 a year 13 hours ago Qualifications Project reporting Manufacturing management Procedural guides ERP systems Metrics Reporting MRP Data summary reports Manufacturing standard operating procedures Manufacturing facility experience Team development Schedule management Sales and operations planning (S&OP) Headcount forecasting Leading team collaboration initiatives Collaboration with manufacturing teams Biomedical regulatory compliance Managing manufacturing teams Productivity software Factory experience Cross-functional team management Production scheduling Production documentation Manufacturing company experience Team motivation (leadership skill) Cross-functional communication Strategic workforce planning

Full Job Description Position Summary:

The Manufacturing Manager ensures the production of all assemblies required for the S250i are completed on-time and with the highest quality. Additionally, the Manufacturing Manager will ensure all facets of world class production techniques are achieved. The

MEVION S250

Series is built in a low-volume, high-complexity environment in which each system carries the scope and risk of a capital project. Accordingly, this position is measured on repeatable execution against commit dates rather than on unit throughput. This position does not hold design authority, controlled document ownership, or authority to hold or release a build. Where build readiness is at risk, the Manufacturing Manager is accountable for developing the supporting factual case and escalating it through the established governance path in time to be acted upon. The Manufacturing Manager will directly report to the Director of Manufacturing.

Essential Functions:

Organize and assign work tasks to production leads and personnel in order to meet company goals and objectives. Ensure products meet designed quality specifications and achieve established quality goals. Apply lean production methods within manufacturing's span of control, including standard work adherence, 5S, and visual performance management, and drive continuous improvement of overall manufacturing efficiency. Maintain and improve the production environment, which includes layout of the floor and material flow, development and maintenance of tools and equipment, and proper utilities and environmental controls. As well as maintaining clean, safe working environment. Motivating, supporting and providing guidance to production staff. Ensure that training, test, and maintenance methods and processes are executed in a manner that supports all quality standards, and that personnel are trained and qualified to the current released revision. Coordinate with Supply Chain, Planning, Logistics, Engineering, and Quality to sequence activities efficiently. Ensures project/department milestones/goals are met on time Communicate build status, risk, and issues impacting production to management on the established reporting cadence. Maintain accurate build status and capacity data for Planning, Program Management, and the SIOP process. Supervise factory testing of the S250 accelerator module and related equipment. Oversee factory commissioning of the S250 at the Littleton facility, including cabling, startup, preliminary testing, troubleshooting and repair, and final testing. Manage the day-to-day activities of the Test & Commissioning Engineers and production floor staff. Own execution of the daily and weekly build plan for assigned systems against the released schedule in the ERP system, including work order release readiness, kit verification, in-process status, and closure. Accountable for root cause investigation and permanent corrective action on manufacturing-caused nonconformances. Distinguish manufacturing-caused issues from design, supplier, and documentation causes and route each to the responsible owner with supporting evidence. Drive elimination of repeat nonconformances. Repeated containment of the same issue is not an acceptable steady state. Verify build execution against documented process at the point of work rather than through reports alone. Represent Manufacturing in Material Review Board, CAPA, internal audit, and external audit activity, and ensure device history record accuracy for assigned systems. Serve as the required manufacturing reviewer on engineering changes affecting active or released builds, providing a documented manufacturability and build-impact assessment within the review window. Approval authority rests with Engineering and Quality. Provide a build readiness assessment at engineering transfer covering drawing completeness, work instruction availability, tooling, fixtures, and skill coverage. Escalate readiness gaps with supporting data, including affected work orders, hours at risk, and schedule impact. Identify work instruction and process documentation discrepancies found during execution, submit them through the change control process, and track them to closure by the document owner. Own the cross-training and skill coverage matrix for all critical operations. Identify single-point skill dependencies and close them against a stated plan. Build problem-solving capability at the lead and technician level so that routine issues are resolved at the floor without manager escalation. Set and cascade team objectives aligned to manufacturing and company goals, and conduct performance reviews, development planning, and succession planning for the production organization. Manage hiring, onboarding, and retention for the production organization as headcount scales.

Education, Training and Experience:

Bachelor's degree in Engineering (preferred), Manufacturing, Industrial Technology, or Business Administration, or equivalent relevant education and experience. 7+ years manufacturing experience, including 3+ years directly managing a production team. Experience in a low-volume, high-mix, high-complexity build environment such as medical capital equipment, semiconductor capital equipment, aerospace, or defense. High-volume repetitive manufacturing experience alone is not sufficient for this position. Working knowledge of a regulated quality system, such as ISO 13485 or

FDA 21 CFR

Part 820, including nonconformance, CAPA, device history record, and change control practice. Hands-on ERP and MRP proficiency (Rootstock preferred, comparable tier-one ERP acceptable), including work order lifecycle, scheduling logic, lead time maintenance, and shortage reporting. Demonstrated data literacy. Able to build, defend, and act on operational metrics derived from ERP data without dependence on IT support. Direct experience authoring or enforcing standardized work and work instructions. Ability to convert a demand plan into labor hours, work center load, and a supportable headcount position. Able to present manufacturing status, capacity, and performance at a summary level to executive and cross-functional audiences in SIOP, program review, and similar forums, and to defend the underlying data under questioning. Strong organizational and motivational skills. Demonstrated interest and ability in developing manufacturing team. Strong teamwork, communication, and decision-making skills. Effectively manage changing and multiple priorities. Proficient with Microsoft Office Suite.

Preferred Skills:

Ideal qualities include being a good communicator, a collaborative working style, high standards for quality, adherence to process, a bias towards action and decisiveness. Knowledge of a manufacturing lean production system utilizing standard work, 5S, visual performance management, and working knowledge of OEE is strongly preferred. Knowledge of ERP and shop floor data acquisition beyond transactional use, including report and dashboard development (Rootstock and Salesforce preferred). Documented track record of permanently eliminating a recurring defect, rather than containing it. Formal problem-solving training or certification such as A3, 8D, or Six Sigma Green Belt or above. Experience operating within a PMO or PMBOK governance structure, including participation in SIOP or S&OP. Experience scaling a production organization through a step change in annual output. Experience with high magnetic field, cryogenic, vacuum, RF, or radiation-producing equipment.

Physical and Environmental Considerations:

Must be able to sit and stand for long periods of time. Must be able to walk through the factory environment safely. Typical office and lab environments. Must be able to use standard office equipment including laptop, copier, phone, etc. The employee will work in high magnetic fields, with high voltages, and with radiation and radioactive materials. The employee may be involved in light rigging operations.