Senior Manufacturing Engineer - Medical Capital Machinery

Senior Manufacturing Engineer

Location: Andover, MA

Target Salary Range: 110-135k - some flex depending on experience
1st Shift - M-F
Setup: Direct Hire

NOTE: Capital equipment experience within a Medical Device environment is required to qualify.

The department of Manufacturing Engineering focuses on manufacturing of the medical devices in Andover, Massachusetts. The team works on developing, maintaining, and improving manufacturing processes to support our initiative to deliver the highest quality technology to save patients’ lives.

ESSENTIAL TASK AND DUTIES INCLUDE:

• Manufacturing engineering activities associated with the production of medical devices.
• Work hands on with production staff to develop manufacturing processes. Provide support related to existing and new manufacturing processes and work directly with production staff to improve, maintain, and provide support to such processes.
• Introduce new products and processes into production including selection, design, installation and maintenance of equipment, tooling, and fixtures used in production.
• Support continuous improvement project initiatives focused on improving product quality and reducing cost.
• Creation of documentation including manufacturing instructions, inspection procedures, test protocols, assembly drawings and component drawings.
• Support engineering team and production team efforts to identify opportunities to streamline production through process improvements, test improvements, and product design changes.
• Work with cross functional teams to identify and resolve technical and quality related issues including participation in MRB, customer complaint investigations, CAPA related activities, design activities, and regulatory submissions.
• Serve as strong team player, supporting and assisting supervisor and colleagues when necessary and comply with all work safety rules and regulations.

BACKGROUND AND QUALIFICATIONS:

• Manufacturing engineering experience in an FDA/ISO regulated Medical Device/ Medical Equipment Industry.
• Experience with Medical Capital equipment manufacturing and electromechanical devices required.
• Experience in executing Process Development and/or Manufacturing Engineering activities including the development and execution of Process Validation plans to support new and existing process and test equipment.
• Previous work experience in the design, development, and validation of production fixtures and tooling.
• Previous experience working directly with production staff to improve manufacturing processes.
• Previous work experience with validation and implementation of plastic assembly, hardware assembly, Electromechanical assembly, and test processes.
• Ability to work with Solidworks, and/or Pro Engineer to create 3D models and drawings to support manufacturing assembly models, fixture design and development, and sustaining engineering activities.
• Experience using Minitab or similar statistical evaluation software/tools, Lean Six Sigma experience and knowledge of statistical data analysis techniques is a plus.
• Experience with Root Cause Investigations and CAPAs.
• Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities.
• Must have ability to identify, prioritize, and resolve issues as they arise with minimal supervision.
• Must possess a strong work ethic, effective oral and written communication skills, and excellent interpersonal skills.

EDUCATION:

• BS in Engineering plus 5-8 years of experience working in an FDA/ISO regulated Medical Device/ Medical Equipment Industry, or equivalent education and years of experience.