Senior Manufacturing Engineer

CONMED   •  

Largo, FL

Industry: Medical Devices & Diagnostics

  •  

5 - 7 years

Posted 301 days ago

This job is no longer available.

Job Summary
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The Senior Manufacturing Engineer applies engineering principles to the planning, design, manufacturing process development, documentation, and testing of surgical devices / equipment.  Demonstrated knowledge in Design for Manufacturability, Lean Methodologies / Tools, Design of Experiments (DOE), Statistical Process Control (SPC), and product and process characterizations.  Development of Process Failure Mode Effect Analysis (pFMEA) during manufacturing process development and change.  Investigates product failures and develops methods to prevent recurrence.  Must be familiar with CAPA process.  Defines approaches to test method operation, implementation and provides training of the test methodology.  Design transfer and validation of new products.

Duties and Responsibilities:

Develop SOPs and manufacturing instructions and update existing documentation as needed in a timely manner

Conduct root cause analysis and lead CAPA investigations

Focus on critical deliverables and high priority projects, acting as a hands on resource

Ability to create and execute characterization protocols and design of experiments

Drive test method improvements

Ensure Good Manufacturing Practices (GMP) are applied

Experience in the utilization of SolidWorks CAD and analysis tools

Create and implement verification and validation plans for systems and subsystems

Ensure all FDA and related regulatory requirements are consistently met

Explore and pursue innovation/technologies and integrate them into the manufacturing operations

Participates in research and development activities as the manufacturing engineering representative

Responsible for design transfer from R&D to an internal manufacturing site under a regulated medical device environment.  This individual will drive day to day activities will include conducting research, data analysis and process development studies to support design transfer activities. The candidate will also participate in cross-functional project teams, and author and/or review protocols and technical reports to support the Device Master Record (DMR).

Define problems and objectives, develop approach, analyze results and provide recommendations

Proactively develop and maintain technical knowledge in specialized area(s), remaining up-to-date on current trends and best practices

Supports post-launch to resolve performance and/or quality issues

Lead the design, execution, analysis and study documentation to support new product launches

Design & implementation of automation technologies within the manufacturing operations leading to overall quality & efficiency improvements

Define and translate new product requirements into product designs and performance specifications

Collaborate with internal and external partners to achieve project objectives and deliver timely innovative solutions to meet business needs

Incorporate appropriate statistics methods into experimental design and analysis

Qualifications
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Bachelor’s degree in Mechanical, Manufacturing, or Automation Engineering, with a minimum of 5+ years of experience or Masters of Science degree with 3+ years of experience in the medical device industry

Experience in medical device specifically in surgical devices / equipment 
   
Knowledge of FDA / ISO quality systems specifically Design Controls / Product Development Process & 21CFR820 and related requirements.
   
Understanding of product development and manufacturing methodologies to achieve high quality designs (design reliability) & manufacturing yields
   
Experience in the utilization of SolidWorks CAD and analysis tools
   
Demonstrated skills in the following areas:  Mechanical / systems design, design for reliability / manufacturability, CAPA, materials and component selection, test fixture design, hydro pneumatic and fluidic sub-system design, design characterization, verification, and validation activities, excellent communication skills, ability to lead projects within own functional discipline, root cause analysis / problem solving
   
Experience in the design & implementation of automation technologies within the manufacturing operations leading to overall quality & efficiency improvements
   
Hands-on experience with Lean Methodologies / Tools such as 3P

Experience in process Failure Mode & Effect Analysis (pFMEA) and risk analysis

Ensure best practices are being utilized and leading continuous improvements

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