Job Details

Requisition Number 20-0031
Post Date 3/12/2020
Title Sr. Mgr R&D Engineering
City Woodcliff Lake
State NJ
Description Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world.

We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The Senior Manager, R&D Engineer, Interventional Care will support PDI as a leader and technical expert for product engineering & validation working within a dynamic R&D Product Development Team for Interventional Care. He/she will be a key member of a cross functional Core Team that is responsible for creating and delivering innovative technologies against a growth strategy. He/she will be charged and be responsible for managing & validating technologies to result in product delivery with interrelated work-streams. The Senior Manager, R&D Engineer will interact with the other cross-functional team members to enable and accelerate delivery and go/no go decisions as well as extended team members from across the organization, ensuring strong connectivity, provide leadership and technical guidance.

Finally, the Senior Manager, R&D Engineer will foster and develop crucial technical competencies with the R&D Engineering team(s) so that the team is positioned to exceed expectations against core competencies and customer connectivity.


ESSENTIAL FUNCTIONS AND BASIC DUTIES

Responsibilities include leading the development, validation and execution of R&D product development in addition to functional engineering leadership of the Interventional Care portfolio. This includes providing leadership to design development driven by customer insights and quality by design principles (QbD) that to create products that meet the high standards aligned with PDI’s mission.

She/he will be a key member of a cross functional core team responsible for delivering a pipeline of products to drive growth against strategy. She/he and will also assist in the leadership and implementation of an organizational structure that supports the successful delivery of products to market, both internal and external, within the scope and timing defined by PDI’s strategy. She/he collaborates with all critical cross functions to produce high-quality products that satisfy customer needs.


Leadership and Management

• Reinforces PDI’s culture and values, and drives change where needed to increase alignment with those goals.
• Identifies departmental technical competency gaps and creates a strategy improve technical competencies.
• Develops staff through coaching, training, and other relevant experiences. Builds high performance teams.

Project Management

• Operates effectively in a multi-tasking, cross-functional environment, including managing network external collaborators and experts
• Analyzes and provides clear direction in areas of ambiguity or uncertainty, maintaining momentum and achieve alignment with cross-functional partners in these areas.
• Demonstrates intellectual agility to work effectively and efficiently in a highly regulated space, exhibiting the ability to identify and assess opportunities for prudent risk taking.
• Develops appropriately proactive resource plans and utilizes staff and other resources effectively to meet area/partners’ needs. Uses appropriate tools to regularly review, measure, modify, and adjust plans and to monitor the efficiency, effectiveness and balance of resources according to evolving business needs and environment.
• Guides internal/external debate and discussions at high levels and focuses constituents towards resolution around strategic and tactical decision making.
• Models good decision-making practices and assesses and rewards behaviors consistent with good decision making practices.
• Displays strong analytical and strategic thinking.


Technical Expertise

Supports the Interventional Care Core team as a Product Engineering subject matter expert. Lead the overall approach, development, validation, supplier qualification and commercialization of new product development and packaging. Be the primary technical resource for PDI colleagues on any and all design verification and validation.

Leads verification & validation for new products
• Leads the alignment of consensus standards and design verification practices
• Leads test methods development and validation
• Leads collaborative and independent thinking to optimize test plans
• Leads design reviews for all new products
• Works with design lead to develop and validate prototypes
• Generates Intellectual Property Strategy with PDI Counsel including disclosures forms, design/utility patent applications
• Supports the development of Regulatory Strategy

Develop specifications for new materials and technologies
• Validates testing to support a new specification
• Compiles and validates test data
• Drafts specification and reviews with appropriate team members
• Issues a new component or finished good specifications for approval

Train IC Product Engineering members and other PDI technical colleagues
• Creates and updates training presentations with information specific to the target internal audience
• Gives training presentations to various stakeholders

Prioritize day to day work of the Interventional Care engineers
• Evaluate workload versus available resources
• Work with other internal functions to ensure adequate and timely support; including R&D Package Engineering, Non-wovens Engineering, other technical services.

Benchmarking of all competitive products and product packaging
• Benchmark current and new packaging technologies and use this information to provide recommendations to the Core Team on their selection of packaging materials.
• Maintains a depth of expertise related to PDI’s core business
• Executes industry and academic publication related to PDI’s core technologies.




Requirements QUALIFICATIONS

EDUCATION/CERTIFICATION:
Bachelor of Science in Mechanical Engineering, or equivalent from an accredited program

REQUIRED KNOWLEDGE:
Technical knowledge of Product Engineering including Design Verification and Validation; FDA Regulated Environment complying to USP and ISO13485 guidelines

Must have extensive experience in engineering-related business needs and comprehensive knowledge of the competitive landscape. Required technical knowledge:
• Medical device engineering
• Knowledge of ISO13485 and/or USP guidelines
• Durable Devices / Durable Medical Devices
• Plastic Molding Technologies
• Sealing Technologies
• Production Equipment
• Comprehensive knowledge of ASTM / TAPPI test methods
• Expertise running test method validation (IQ, MSA)

Ability to author and or review protocols, lab notebooks, reports, SOP’s, and specifications

EXPERIENCE REQUIRED:
• A minimum of ten years relevant experience in product engineering and/or product development with a proven track record bring innovative products to market
• Knowledge of validation techniques
• Knowledge of production equipment
• Depth of understanding of the product development and change control processes

SKILLS/ABILITIES:
• Must have excellent communication & project management skills
• Experience leading technical engineering projects
• Capacity to work in a fast-paced environment, with multiple projects of varying complexity
• Proven track record in the management of intellectual property
• Knowledge of standards and regulatory requirements which guide FDA regulated products.
• Computer skills: MS Office, Solidworks or Creo, Adobe, and Minitab.

WORKING CONDITIONS

NONE: Typical office environment

#LI-PDI
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INTENT AND FUNCTION OF JOB DESCRIPTIONS

Job descriptions assist organizations in ensuring that the hiring process is fairly administered and that qualified employees are selected. They are also essential to an effective appraisal system and related promotion, transfer, layoff, and termination decisions. Well-constructed job descriptions are an integral part of any effective compensation system.

All descriptions have been reviewed to ensure that only essential functions and basic duties have been included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. In no instance, however, should the duties, responsibilities, and requirements delineated be interpreted as all-inclusive. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

In accordance with the Americans with Disabilities Act, it is possible that requirements may be modified to reasonably accommodate disabled individuals. However, no accommodations will be made which may pose serious health or safety risks to the employee or others or which impose undue hardships on the organization.

Job descriptions are not intended as and do not create employment contracts. The organization maintains its status as an at-will employer. Employees can be terminated for any reason not prohibited by law.
  • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
  • Please view Equal Employment Opportunity Posters provided by OFCCP here.
  • The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
  • Please refer to the Company’s Substance Abuse Policy which protects the safety and well-being of all associates and potential associates.
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