Job Summary In this role, you will support design and development activities within West's Product Development Process demonstrating leadership and strategic thinking within a goal-oriented organization.
The incumbent will demonstrate accountability for the successful and timely achievement of goals, work independently only with strategic guidance in the most complex situations, interpret internal and external business issues and unmet needs, and take a broad perspective to define/plan/lead/develop solutions.
You may collaborate with local and global functional groups, stakeholders, and management to deliver project goals and meet project milestones.
Essential Duties and Responsibilities Plan and execute projects through all phases with a focus on design and qualification through verification and validation phases.
Facilitate and lead the generation of requirements documentation, risk management documentation (e.g., user and product FMEA) in support of R or equivalent experience Master's Degree Mechanical or Biomedical Engineering preferred; or equivalent experience Work Experience Minimum 5 years experience in the medical device or combination product industry required Experience in high-volume, automated manufacturing processes, and glass forming preferred Experience in Human Factors for Medical Devices preferred Expertise with test method development, validation strategy, and execution required Preferred Knowledge, Skills and Abilities Working knowledge of ISO *****, ******** (MDR) and 21 CFR Part 820 is essential Expertise with risk management, design verification and validation strategy development and execution Expertise in medical device design control and change management Experience with combination products requirements and regulation Proficiency in CAD solid modeling/drafting Proficiency in solid mechanics/mechanics of materials Proficiency in statistical methods/tools Proficiency in project management Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies Ability to lead and teach others to assess project/program needs, formulate strategies, build support, and execute initiatives Strong interpersonal and decision-making skills and the ability to effectively manage change and uncertainty Knowledge of applicable ISO, and USP standards for drug delivery Knowledge of applicable health authority regulations including FDA, MDR Ability to comply with the company's safety and quality policies at all times Travel Requirements 20%: Up to 52 business days per year Physical Requirements Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body.
Sedentary work involves sitting most of the time.
Additional Requirements Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Position operates in a professional office environment.
May stand or sit for extended periods of time Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities 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 Ability to make independent and sound judgments Observe and interpret situations, analyze and solve problems Able to perform Research and Development lab activities 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 What We Offer This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week Shift Day shift: 8am - 5pm Hybrid role: 2 days wfh and 3 days on-site West embraces diversity and equality of opportunity.
We foster an environment where all individuals are safe, treated fairly, valued and respected.
We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics.
Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening.
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