Forward Deployed Software Engineer engaging directly with customers to support enterprise solutions. Balancing hands - on interaction and internal collaboration for secure deployments.
About the role
- Senior Engineer supporting equipment design and process implementation at Validation & Engineering Group. Focused on pharmaceutical, biotechnology, chemical, food, and medical devices industries.
Responsibilities
- Support equipment design and process implementation activities under the guidance of the Staff Engineer
- Contribute to the design, development, and integration of manufacturing equipment, ensuring alignment with project requirements and operational standards
- Assist in developing User Requirement Specifications (URS) and mechanical/electrical designs for assembly and packaging equipment
- Support the integration of new equipment through SAT completion, Equipment Integration during install, FAT and startup
- Support Process Design on new equipment and ensure product designs are being met
- Provide feedback and validate that the equipment design meets safety and operational standards based on experience and validation from respective stakeholders
- Support suppliers and external design teams (vendor) for larger capital projects to manage cost, lead time and scope
- Responsible for vendor contracts in collaboration with procurement and legal
- Create, or obtain from the vendor, detailed 3D models/2D drawings of mechanical components and assemblies using CAD software
- Create and maintain design documentation, including user requirement specifications, assembly instructions, bill of process, etc.
- Support equipment designs to minimize production costs and changeover time, simplify assembly processes, design from the operators standpoint, maintainability, and ensure manufacturability
- Participate in equipment design reviews, risk assessments, and continue to build failure mode and effects analysis (FMEA) to ensure reliability, safety, performance of mechanical systems/equipment
- Collaborates with manufacturing teams to build and test prototypes of mechanical systems and components, gathering feedback, iterating on design as necessary
- Support various engineering analyses / simulation (i.e. stress, strain, thermal, fluid dynamics) to validate and optimize design
- Work closely with other engineering fields and Maintenance teams (i.e. electrical/mechanical engineers) to ensure seamless integration of mechanical systems with other project components
- Comply with all local, state, federal, and BD safety regulations, policies, and procedures
- Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles
- Other duties as assigned
Requirements
- Bachelors degree in Mechanical, Electrical, Chemical, or Industrial Engineering (Masters preferred)
- 8+ years of engineering experience in pharmaceutical/medical devices industry
- Tooling design experience of complex mechanical systems is preferred
- Experience with PLC programming and Controls
- Proficiency in Autocad and/or SolidWorks is desired
- Excellent technical skills including project management, organization, and planning
- Demonstrated ability to apply problem solving and data analysis methods
- Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts desired
- Experience in an FDA regulated quality environment desired
- Willingness and ability to travel domestically and internationally up to 25% average annually
Benefits
- Ability to use a laptop/computer for extended periods of time (up to 8 hours)
- Ability to sit for long periods of time (up to 8 hours) in virtual and/or on-site meetings
- Ability to stand for long periods of time (up to 8 hours) when conducting FAT, SAT, on-site equipment/process troubleshooting, etc.
- Ability to climb steps, squat, etc.
- Follow Safety and Quality/GMP requirements for medical device manufacturing site (Safety shoes, safety glasses, hair net, beard net, face mask, hard hat, etc.as required per manufacturing site)
Job title
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Tech skills
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