Job ID R-302726
Job Description Summary
The associate will have direct responsibility for overseeing and maintaining all BDPAS R&Dengineering labs, development of new test methodologies, the management of laboratory resources, new product/technologydevelopment and product life cycle maintenance.
The primary responsibilities for this position are:
- Effectively recruit, select, develop, organize, and motivate a staff of skilled associates globally (including regional R&D associates, manufacturing sites, and India Design Center-IDC staff as per business strategy).
- Demonstrate strong and clear accountability for the group’s development, performance, and results. Establish a strong succession pipeline.
- Develop creative strategies to improve efficiency (doing more with less) and effectiveness (working on the right things and doing them well) with a focus on innovative solutions under organizational constraints.
- Assess resource demand based on historical usage and project demand based on PAS ASR, regulatory landscape changes, product quality and supply needs with careful attention to building capabilities (both people & infrastructure). Partner closely with NPD, PLE & CTW managers to capture portfolio needs in terms of required competencies and resource demand.
- Participates in corporate-level development of methods, techniques and evaluationcriteria for projects, programs and people. Interprets and recommends modifications to function- and company-wide policies & practices.
- Assists in developing test methods locally and company-wide, including identification of the test equipment and apparatus necessary.
- Advances state of the art in laboratory capabilities by identifying and implementing new technologies for potential innovation and improvement of test methods.
- Advances state of the art in Documentation Control and archiving of records
- Manages resources to support the execution of the PAS projectportfolio aligned with the business objectives. Addresses prioritization issues in a timely and effective manner to support project plans.
- Has responsibility for managing a large sub-function of test engineers, co-ops and temporary employees. Conducts resource planning as needed to support short and long term business needs.
- Coordinates the recruitment, training, supervision, and resource allocation of temporary associates and co-opstudents. Represents BD and manages the selection and recruitment of laboratory co-ops and interns at local universities.
- Works on complex issues where analysis of data requires an in-depth knowledge of the company and products, including all aspects of the product design criteria, product function, and customer use. Furthers product development through knowledge of the clinical and physical performance requirements of specimen collection and handling.
- Ensures training of associates in areas pertinent to
- Laboratory facilities (e.g. the preparation and handling of samples and chemicals; instrument operation, and general laboratory safety); ensures documentation is maintained.
- Oversees design of and/or performs experiments within the scope of project responsibilities and ensures conformance with scientific methods and procedures. Performs or directs data analysis and preparation of technical reports for presentation in written and oral format. Maintains R&D notebook.
- Oversees the product stability program including physical rotation of product in storage, maintenance and control of stability chambers, maintenance of the stability database, and coordinating testing for life cycle stability programs. Maintains schedule for engineering testing to be performed post-product launch.
- Interaction with customers involving negotiations or influencing on matters of significance to the organization.
- Manages the physical laboratory space, its maintenance and control including Personal Protective Equipment, Waste Management, Storage of supplies and test articles, and general upkeep and cleanliness.
- Ensures budgets and schedules meet business unit requirements. Maintains budget for laboratory expenses, including calibration, outside services, supplies, etc. Prepares and submits capital appropriation requests as needed to justify the purchase of new laboratory equipment, renovations, etc.
Ensures product quality and compliance to Good Laboratory Practices regulations as well as Corporate and Unit standards, policies, and guidelines.
Bachelors/Masters/PhD in Mechanical Engineering or related Engineering discipline.
LICENSES OR CERTIFICATIONS:
B.S.: 8+ years of experience in technical area
M.S.: 5+ years of experience in technical area
Ph.D.: 3+ years of experience in technical area
- Knowledge of FDA and ISO Design Control.
- Advanced knowledge of lab equipment and instruments
- Strong technical judgment and extensive technical leadership skills.
- Experience in guiding team/individuals to develop technical solutions to complex problems.
- Sound knowledge of engineering first principles.
- Strong project management, prioritizing and multi-tasking skills to work within tight deadlines.
- Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
- Experience in directing associates and leading small cross-functional groups is required.
- Proficiency with fixture design including basic machining considerations and developing test methods.
- Understanding of Measurement Systems Analysis (MSA).
- Knowledge of Six Sigma (DMAIC) practices, and Design for Six Sigma (DFSS) methodologies.
- Product development considerations for tightly controlled, high-volume manufacturing process.
- Strong creative, analytical and problem solving skills required.
- Good written & verbal communication skills.
- Knowledge of the operation of mechanical measurement equipment required.
- Operation of diagnostic instrumentation preferred
- Must be able to lift 50 lbs.