Manufacturing Engineer

Job Description

Job DescriptionBenefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Manufacturing Engineer

COMPANY OVERVIEW:

Sage Product Development, Inc. provides fast, efficient and creative product development and low to mid volume production services to medical device companies. We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between.

We combine a high level of experience with a low overhead company structure. We solve client companies technical challenges and meet their product development needs in a timely, efficient and highly personalized manner.

We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance their manufacturing engineering abilities, and build their network within the industry.

GENERAL SUMMARY:

• Perform a range of manufacturing engineering tasks on client company projects.
• Meet or exceed customer expectations.

ESSENTIAL JOB FUNCTIONS (all as required by client companies):

• Lead projects to manufacture medical devices. Direct the work of manufacturing technicians.
• Participate in Material Review Board activities. Contribute to decisions regarding product and material discrepancies and actions to prevent subsequent problems or discrepancies.
• Perform all work in an organized, orderly, safe, compliant (ISO 13485:2016, 21 CFR 820) and controlled manner.
• Assist the Production Manager in scheduling production work to meet client companies needs, prevent bottlenecks, ensure orderly workflow and maximize efficiency.
• Ensure that all manufacturing documentation is thorough, complete, and properly stored and controlled.
• Identify resources required to complete manufacturing jobs.
• Complete IQ/OQ/PQ activities as required.
• Identify, specify and procure manufacturing equipment as required to meet production needs.
• Assist the Production Manager in performing materials management functions, including supplier management, supplier qualification, materials ordering, materials processing, inventory management, etc.
• Provide manufacturing engineering expertise to product development projects. Contribute to the product development process by utilizing Design for Manufacturing, Design for Assembly, 5S, lean engineering, six sigma, or other methodologies.
• Generate and maintain Process FMEAs.
• Contribute to the design of tools, fixtures and processes for device assembly.
• Generate and maintain assembly procedures and routings.
• Generate labels and label artwork using Bartender, CodeSoft software and Zebra printer platforms.
• Provide estimates of manufacturing costs to support the proposals.
• Design and implement new methodologies, materials, machines, processes or products as required to achieve manufacturing goals.

General:

• Interact with client companies and Sage team members in a professional and courteous manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.
• Prepare daily timesheets and submit completed timesheets on a weekly basis.
• Prepare documentation release and change packages for production documentation. Approve Document Change Orders (DCOs) and obtain approvals from others as required.
• Ensure that all work satisfies the requirements of Sages or the client companies Quality Systems.
• Some local travel (i.e. by car). Occasional long-distance travel (i.e. by plane).

OTHER DUTIES AND RESPONSIBILITIES

• Any other duties as assigned.

REQUIRED COMPETENCIES

Customer Focus

• Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers needs and take appropriate action. Follow through on customers inquiries in a professional and timely manner.

Management of Resources

• Work in an organized and time effective manner. Proactively seek out relevant reference materials as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.

Communication Skills

• Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong verbal presentation and negotiation skills. Interact with client company personnel in a positive and professional manner. Express ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES:

• Bachelor's degree is required, preferably in Mechanical or Industrial Engineering. Masters degree in engineering, management or business is a plus.
• Some prior medical device manufacturing engineering experience is required.
• Ability to interact with client companies in a professional manner.
• SolidWorks 3D CAD proficiency is a plus.
• Knowledge of probability and statistics, proficiency in Minitab software is a plus.
• Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

SUPERVISORY RESPONSIBILITY:

• May direct the work of other people and may have direct reports.

REPORTS TO:
Director of Manufacturing

WORKING CONDITIONS/PHYSICAL DEMANDS:

• Must be able to move throughout manufacturing, office and laboratory space, using a complete variety of office equipment, machinery and tools. Must be able to lift more than 25 pounds and stand for extended periods of time.
• Must be able to wear cleanroom gowning items (head cover, coat, gloves, shoe covers, facial covering if needed) and work in cleanroom environment for extended periods of time.
• Must be able to work with chemicals found in a manufacturing environment.
• The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.
• External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.