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 for pharmaceutical industry. Collaborating with cross-functional teams and managing vendor contracts and mechanical systems.
Responsibilities
- 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.
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.
- 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.
- Strong communication skills.
- Risk analysis / FMEA.
- Statistical analysis / SPC system.
- Ability to manage multiple conflicting priorities, and to develop and maintain tool qualification schedules.
Benefits
- 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
Job type
Experience level
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Degree requirement
Tech skills
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