Job Description

Job Summary

The Sr. Manufacturing Engineer will lead a small team of Engineers, CNC Programmers and the tool crib. They will also take on their own engineering project work (player/coach) and be a project manager for the Engineering Department.As a leader of the department, they will provide direct oversight, leadership, and accountability for the Engineering department. Schedule, coordinate, and supervise the work of all departmental operatives and own the relationship between the development and production teams. They will oversee the development and implementation of manufacturing processes, ensuring that the manufacturing process delivers functional and quality projects safely, on time, and at or below budget requirements. Serve as a key stakeholder and display ownership of the department's ability to demonstrate compliance with the ISO (International Organization for Standardization) standards, FDA (Food and Drug Administration) regulations, and the company quality system.

This position is also responsible for the design and operation of integrated manufacturing systems for the production of company products, ensuring efficiency, quality, and on-time delivery. You will be a project manager who leads the implementation, monitors success or failure, examines lessons learned, documents the process, and reports results.      

Essential Job Functions

• Lead the design and development of new and existing hardware and products and ensure effective integration into the production process.  
• Drive continuous improvement of design for excellence practices and new product introduction.  
• Act as a force of cost reduction in design, production, and supply chain process.
• Work with vendors, design engineers, and production to continuously deliver parts designed for manufacturability, reliability, and source-ability.
• Develop strategies that drive measurable yield improvement, production efficiency, risk reduction, and process improvement.  
• Execute departmental work plans in conformance with company policies, procedures, regulations, best practices, management objectives, priorities, and financial impact. Supports interdepartmental cooperation.
• Administer the Environmental Health and Safety Program
• Read, interpret and adhere to drawings, blueprints, manufacturing specifications, work instructions, regulations, manuals, and quality procedures.
• Design and implement effective workgroups and systems and proactively drives the progress of work.
• Drive On-Time-Delivery (OTD) and Quality metric targets; seeks opportunities to increase productivity and eliminate waste.
• Attend and participate in management meetings and reports on key metrics. Reports performance statistics up the chain of command and recommends strategic changes.
• Resolve personnel and employee relations issues and performs annual employee reviews.
• Recruit, hire, mentor, manage, and train employees and assist them in performance improvement and accomplishing business objectives. Ensure department personnel receives job-relevant training.
• Liaise with customers, suppliers, and third parties as necessary, including monitoring the progress of work.
• Exemplify good work practices, behaviors, and leadership traits; operates with integrity, treats others with respect, demonstrates reliability and teamwork, initiative and creativity, problem-solving and decision making.
• Demonstrate clear and effective communication, both verbal and written. Prepares, maintains, and submits accurate paperwork as required, including job reports, timekeeping records, etc.
• Adhere to all applicable environmental, safety and health, and operations procedures and directives. This includes the proper use of personal protective equipment in accordance with manufacturer specifications, Safety Data Sheets (SDS), and company guidelines.  
• Ensure job site safety promotes safe work practices and rectifies job site hazards, including clean work areas.
• Read, understand, write, and interpret the lockout/tag-out indicators in the work area.     
• Know, understand, and adhere to Company organizational policies and procedures; aligns with and represents the Company's mission, vision, and core values.
• Regularly report to work on time, maintain acceptable attendance requirements, and work overtime as required.
• Perform other related tasks as assigned, some of which may become essential to the position.
• Apply Lean manufacturing principles to improve production processes and achieve cost reduction.
• Plan, define and implement new manufacturing systems as needed for new product introductions (ownership of the NPI process).
• Contribute to investigations on production-related deviations of batches, equipment, and facilities to ensure all CGMPs, SOPs, and customer requirements are met.
• Perform other related tasks as assigned, some of which may become essential to the position.

Skills and Abilities

Required Skills and Abilities

• Must be able to understand, read, write and speak English.
• Demonstrated abilities in problem-solving, critical thinking, and mathematics.
• Developed organizational skills and a high level of attention to detail.
• Exceptional interpersonal and communication skills and a demonstrated ability to motivate and lead by example, fostering a culture of positivity and encouragement.     
• Skilled in the use of Microsoft Office programs (i.e. Outlook, Word, Excel).
• AutoCAD/DraftSight and SOLIDWORKS
• Skilled in the use of the tools-of-the-trade.
• Must be able to wear safety equipment, as required.

Preferred Skills and Abilities

• GibbsCAM, Mastercam, Vericut, or other relevent software applications.
• Minitab software for statistical analysis

Knowledge and Experience

Required Knowledge and Experience

• A minimum of 5 years of experience in a related job role with lean manufacturing experience.
• Bachelor's degree in an engineering discipline.
• Or any equivalent combination of education, training, and experience that demonstrates the ability to perform the duties and responsibilities as described, including an internship in relevant trade.  
• 3+ years of supervisory/management experience in a manufacturing environment.
• A proven track record in process improvement.

Preferred Knowledge and Experience:

• Project Management Professional (PMP) certificate
• Lean/Six Sigma Certification
• Medical device manufacturing experience
• Possess and demonstrate a thorough understanding and a working knowledge of all phases of the job.

Physical/Mental Involvement & Environmental Factors

Physical Requirements: While performing this job's duties, employees are regularly required to sit, walk, stand, bend, crouch, crawl, and twist. Reach, push, and pull with hands and arms.  Lift to 50 pounds.  Talk and hear, both in person and by telephone.

Mental Requirements: Employees are regularly required to use written and oral communication skills; read and interpret data, information, and documents; analyze and solve non-routine and complex problems; use math and mathematical reasoning; observe and interpret situations; learn and apply new information or skills; perform highly detailed work on multiple, concurrent tasks; work under intensive deadlines with frequent interruptions, and interact with staff, the public.

Working Conditions: 100% of work takes place inside an industrial office/warehouse environment.  Employees work in proximity to moving machinery, mechanical parts, and vehicles and may have exposure to prolonged loud noise, including sirens, horns, and tooling.  Employees may handle hazardous material or have exposure to toxic or caustic chemicals, biological hazards, and airborne fumes. The noise level is usually mild to moderate 75% of the time. 

Disclaimer

Job descriptions are not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee.  Other duties, responsibilities, and activities may be assigned or changed at any time with or without notice.  Job descriptions are developed through observation of work, information from the marketplace, and interviews with workers and supervisors currently performing the job.