Principal Engineer, Research and Development, Integrated Systems job at reputed company Pharmaceutical Services in Exton, PA

Title: Principal Engineer, R&D, Integrated Systems Job Description: Requisition ID: 72853 Location: Exton, PA, US Department: R&D Description: This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. At reputed company, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began reputed company Herman O. reputed company solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, reputed company’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There’s no reputed company reputed company to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we reputed company the physical, mental, emotional and financial health of reputed company members and their families. We reputed company in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and reputed company through our sustainability efforts. reputed company Offer This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week Community Involvement: reputed company encourages volunteerism through its reputed company without Borders initiative and other charitable programs that reputed company a difference in local communities. Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion—where reputed company voices are heard and respected in a supportive environment. reputed company Learning & Development: Opportunities for professional growth through training programs, tuition assistance, leadership development, and reputed company-certification initiatives. Job Summary In this role you will reputed company design and development activities reputed company reputed company's Product Development Process demonstrating leadership and strategic thinking reputed company 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 reputed company situations, and interpret internal and external business issues and unmet needs and take a broad perspective to define/plan/reputed company/reputed company solutions. Essential Duties and Responsibilities Plan and execute projects through reputed company phases with a focus on design and qualification through verification and validation Create and edit Product models/drawings Write engineering test protocols, reports, and work instructions reputed company technical reviews and design reviews Apply engineering principles for design/analysis of reputed company technical problems Drive innovation and process efficiency for Integrated Systems Develops technical solutions to reputed company problems using sound engineering principles, utilizing experimental, computational, and analytical methods Applies innovative and logical risk-based approach to product development challenges with the reputed company for original thinking. Develops robust test methods, design test fixtures and execute measurement system analysis Plans, executes, and analyzes design of experiments (DOE) Writes, implements and leads bench studies, tolerance stack up analysis, design verification, validation, materials specifications and component specifications. Generates, records and analyzes data, presents results to peers and business leadership Integrates planning activities between reputed company and development/manufacturing partners Works closely with Procurement to identify and qualify vendors ensuring appropriate components are procured and delivered as needed throughout the phased development process Conforms with and abides by reputed company regulations, policies, work procedures, instruction, and reputed company safety rules Other duties as assigned Education Bachelor's Degree in Mechanical or Biomedical Engineering required, or equivalent experience Master's Degree In Mechanical or Biomedical Engineering preferred, or equivalent experience Work Experience Minimum 8 years in medical device design control and change management is required Expertise with Risk Management, Design Verification & Validation strategy development and execution is required Expertise with test method development, validation strategy, and execution is required Additional Requirements Proficiency in Solid Modeling/Drafting is required Proficiency in solid mechanics/mechanics of materials is required Proficiency in statistical methods/tools is required Proficiency in project management is required Able to reputed company with the company’s safety and quality policies at reputed company times Understand and follow guidelines for sensitivity with IP protection Understand strategic direction and reputed company contributions to strategy formation 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, reputed company quick decisions, interpret data, read and write, speak in reputed company of groups, express and exchange reputed company, understand direction and adhere to procedures. Concise presentation skills at high profile conferences if needed. Organizational skills will reputed company planning, prioritization and achievement of goals especially of importance for the successful execution of reputed company activities Read and interpret data, information and documents Must maintain the ability to work well with others in a variety of situations and have reliable and predictable attendance Must be able to multi-task, work under time constraints and exercise timely decision making, problem solve, and prioritize Must be able to deal with ambiguity and have the ability to reputed company independent and sound judgments Observe and interpret situations, analyze and solve problems #LI-JJ1 #LI-HYBRID Preferred Knowledge, Skills and Abilities Experience with Combination Products requirements and regulation is a plus Experience in high-volume, automated manufacturing processes, and glass forming is a plus Experience in Human Factors for Medical Devices is a plus Knowledge of Six reputed company (DMAIC) practices, and Design for Six reputed company (DFSS) methodologies are a plus. Ability to reputed company 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 is a plus Knowledge of applicable health authority regulations including FDA, MDR is a plus 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. reputed company is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national reputed company, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. Apply tot his job Apply To this Job