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West Pharma Senior Associate Product Engineering United States, Pennsylvania, Radnor Township 186449714
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Job Summary
You will thrive if you are a self-starter and critical thinker with an agile mindset on innovative technology development to identify and prioritize activities needed to advance programs from a technology standpoint.
Essential Duties and Responsibilities
- Design and develop prototypes to advance West’s containment and drug delivery device portfolio, focusing on novel, disruptive technologies.
- Lead, plan and execute new product development projects through all phases with a focus on design, prototyping, and engineering testing
- Generate CAD drawings and engineering drawings that can be prototyped using 3D printing and other rapid prototyping equipment. Perform prototype testing/assembly and troubleshooting in early feasibility stages.
- Analyze and evaluate device performance to make well-reasoned strategic recommendations for design improvement that can advance product feasibility milestones to inform R&D decisions.
- Independently and collaboratively come up with design concepts for new or modification of existing drug delivery devices/ combination products to meet end-user and/or industry requirements.
- Write, implement, and lead bench studies, tolerance stack up analysis, materials specifications, and component specifications.
- Develop detailed timelines for ensuring engineering milestones are completed on time.
- Facilitate technology transfer of medical devices and combination products from early feasibility to commercialization.
- Solve complex technical challenges that arise on both internal and external projects using own judgement and collaboration and persevere when setbacks threaten project goals.
- Capture project outputs in appropriate format including technical reports, presentation slides, research posters, invention disclosures or as project requires.
- Operate effectively as a leader in assigned roles.
- Manage multiple projects and communicate technical findings to various audiences, including non-technical stakeholders.
- Work Independently and as a Team member with Integrity, Precision, Accomplishment, Motivational Ambition, Respect, and Inclusion.
- Complete all activities with the highest regard for our company and local site procedures for safety, and quality compliance.
Education
- Bachelor's Degree in Mechanical or Biomedical Engineering required
- Master's Degree Mechanical or Biomedical Engineering preferred
Work Experience
- Minimum 5 years' Experience in the medical device or combination product industry.
- Previous experience using SolidWorks required.
- Experience in medical device design, mechanical and functional testing, and failure analysis required.
- Expertise with test gigs and method development, and execution required.
- Demonstrated ability to come up with novel design concepts and develop functional prototypes in medical devices required.
- Demonstrated knowledge of mechanical principles, early-stage feasibility testing, and scaling from prototype to pilot manufacturing required.
Preferred Knowledge, Skills and Abilities
- Experience working with medical device suppliers.
- Experience in Human Factors for Medical Devices.
- Experience in design history file management.
- Familiarity with risk assessments (e.g., FMEA) and design controls for medical devices.
- Knowledge of testing methodologies specific to combination products.
- Experience scaling technologies early-stage feasibility to validation and manufacturing.
- Demonstrated technical experience in injection molding, complex assembly and packaging operations for medical device or combination product component manufacturing.
- Ability to lead and teach others to assess project/program needs, formulate strategies, build support, and execute initiatives.
- Knowledge of applicable ISO, and USP standards for drug delivery.
Physical Requirements
Light-Exerting up to 20lbs/9kg of force frequently, and/or negligible amount of force frequently constantly to move objects.
Additional Requirements
- Read and interpret data, information and documents.
- Must maintain the ability to work well with others in a variety of situations.
- Must be able to multi-task, work under time constraints, problem solve, and prioritize.
- Observe and interpret situations, analyze and solve problems.
- Must be able to deal with ambiguity, use timely decision making, understand sensitivity for IP protection, deliver concise presentations to high-profile conferences, understand strategic direction, make contributions to strategy formation, be reliable and have predictable attendance.
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