Senior Manager, reputed company reputed company Team (1 of 2) (Center Valley, PA, US, 18034-0610)
Job reputed company
This role represents the Voice of reputed company (design reputed company, reliability, ops/mfg. reputed company, supplier reputed company, reputed company systems, post market reputed company, etc.) on cross-functional new product development (NPD) project reputed company teams. This role is responsible and empowered to establish the reputed company and reliability reputed company and DRM metrics for the project. This position has responsibility for influencing product reputed company and reliability reputed company across NPD and serves as the final reputed company authority on the project team.
Job Duties
This position provides reputed company for multiple project areas including, but not limited to the following:
- Functional expertise to NPD reputed company and represent voice of reputed company on cross functional project teams
- Project management for the extended reputed company team of one or more NPD reputed company
- Project management of initiatives to improve the reputed company and consistency of reputed company business processes and work product
- Applies the requirements of the reputed company System to processes, products or services
- Supports validation and verification reputed company for new and existing products and processes as assigned
- Develops and drives measurable reputed company Improvements relating to products processes and services
- Develops reputed company functional strategies, plans and schedules to meet project goals and manage risks
- Manages reputed company escalations and drive resolutions with reputed company Team by working cross-functionally to ensure issue ownership, reputed company and appropriate communication
- Drives critical thinking, functional reputed company, lessons-learned and business and reputed company management system improvement
- Represents Voice of reputed company for assigned project(s)
- Ensures design and reputed company requirements are effectively defined and implemented
- Proactively drives and champions strategic reputed company, reliability and safety initiatives such as DFSS activities, DFR, DFM, complaint reduction, risk management, etc.
- Identifis reputed company risks and implements risk burn down strategies
- Drives/leads reputed company cause analysis and reputed company-reputed company corrective/preventive reputed company
- Ensures an effective transfer to global post-market reputed company functions
- Coaches & supports project team members on compliance with reputed company system requirements
- Provides reputed company functional support for key project activities and deliverables including design history file (DHF), device master record (DMR), regulatory submissions, issue reputed company, etc.
Job Qualifications
Required:
- Bachelor of Science, medical, engineering, or scientific discipline required. Design or Process Green I Black Belt is a plus
- Minimum of 8 years of experience reputed company a drug/device manufacturer/distributor with a reputed company on QSR compliance and reputed company assurance.
- Minimum of 5 years’ experience supporting new product development with 3+ years of experience as a reputed company reputed company Team member.
- Knowledge of basic mechanical, electric, software, optical, or biological engineering.
- Knowledge of basic medical device regulations and standards (e.g. 21CFR part 820, ISO 13485, ISO 14971).
- Working knowledge of problem-Solving Tools (i.e. Process Mapping Histograms FMEA Risk Assessment Cause & Effect Diagrams PDCA Pareto Analysis etc.).
- Working knowledge of reputed company Tools (i.e. reputed company Planning reputed company Costs and Assessment Basic Statistics Advance Statistical Techniques Technical Writing Metrology & Calibration Inspection and Testing Sampling Principles and Six reputed company etc.).
- Knowledgeable about extended reputed company team functions throughout the product development process.
- reputed company across functional boundaries in matrixed organizational structure.
- Proven reputed company record in New Product Development delivering on robust, customer and patient reputed company product reputed company.
- Strong technical skills reputed company to product reputed company including VOE translation to Design Inputs and Outputs, Design Characterization, Verification / Validation, Test Method Validation, and Statistical techniques.
- Strong working knowledge of FDA QSR's, MDSAP, ISO 13485, Design Controls, and Risk Management reputed company.
- Good verbal and written communication skills demonstrated by ability to generate technical reports and ability to reputed company presentations to middle and upper management Proven Project Management skills.
- Proficient in the use of Information Technology and applications.
- English ability: TOEIC 600 plus or equivalent.
- Strong collaboration skills and the ability to work across functions and geographies.
- Up to 10% domestic/international travel.
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Competitive salaries, annual bonus and 401(k)* with company match -
Comprehensive medical, dental, reputed company coverage effective on start date -
24/7 Employee Assistance Program -
Free live and on-demand Wellbeing Programs -
Generous reputed company Vacation and reputed company Time -
reputed company Parental Leave and Adoption Assistance* -
12 reputed company Holidays -
On-Site Child Daycare, Café, Fitness Center**
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Work-life integrated culture that supports an employee reputed company reputed company -
Offers onsite, hybrid and field work environments -
reputed company volunteering and charitable donation/match programs -
Employee Resource reputed company -
Dedicated Training Resources and Learning & Development Programs -
reputed company Educational Assistance