5+ years of manufacturing engineering experience in FDA/ISO regulated Medical Device/Medical Equipment industry.
Proven background in process development and manufacturing engineering, including process validations.
Experience in designing and validating production fixtures and tools.
Hands-on experience improving manufacturing processes with production staff.
Familiarity with SolidWorks and/or Pro Engineer for creating 3D models and drawings.
Knowledge of Minitab or similar tools for statistical analysis; Lean Six Sigma experience is a plus.
Strong problem-solving skills and the ability to work independently.
Responsibilities
Conduct manufacturing engineering activities for medical system production.
Collaborate with production staff to develop and enhance manufacturing processes.
Participate directly in the development and validation of manufacturing processes.
Lead continuous improvement projects to enhance product quality and reduce costs.
Mentor and train junior engineers and interns on manufacturing processes.
Create necessary documentation such as manufacturing instructions and inspection procedures.
Work with cross-functional teams to resolve technical and quality issues.
Benefits
Opportunity to work in a life-saving medical technology environment.
Involvement in continuous improvement and innovation initiatives.
Mentorship and training opportunities for professional growth.
Collaborative team culture fostering support and knowledge sharing.
Full Job Description
Job Description :
Contract Senior Manufacturing Engineer Reports to:
Manufacturing Engineering Manager Department of Manufacturing Engineering focuses on manufacturing at our headquarters 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 Tasks and Duties:
Manufacturing Engineering activities associated with the production of medical systems.
Work with production staff to develop manufacturing processes. Provide technical expertise and support related to existing and new manufacturing processes and work directly with production staff to improve, maintain, and provide support to such processes.
Work hands on to develop manufacturing processes, participate in validation activities, data collection and analysis of production process.
Complete continuous improvement project initiatives focused on improving product quality and reducing cost.
Provide mentorship and training to Jr level engineers and interns. • Creation of documentation including Manufacturing Instructions, Inspection procedures, Test Protocols, Assembly drawings, equipment control documentation, and Component Drawings.
Lead activities with the Engineering and Operations teams 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:
Must have manufacturing engineering experience in an FDA/ISO regulated Medical Device/ Medical Equipment Industry.
Must have prior Process Development and/or Manufacturing Engineering experience including the development and execution of Process Validations to support new and existing process and test equipment.
Must have prior experience leading the design, development, and validation of production fixtures and tooling.
Previous experience working directly with production staff to improve manufacturing processes.
Must have prior work experience leading the development of plastic assembly, hardware assembly, electromechanical assembly, and test processes and validations.
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 leading 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
EDUCATION: • BS in Engineering plus 5+ years of experience working in an FDA/ISO regulated Medical Device/ Medical Equipment Industry, or equivalent education and years of experience.
