Engr 3, Product Development

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Job description

Onsite at least 3 days a week. Must be local

3 Must haves on the resume:
1. Knowledge of medical device development and manufacturing
2. Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation
3. Ability to create and execute project plans and ability to lead cross functional teams.

Position Summary:
This position is a temporary assignment that will support EU-MDR efforts and is anticipated to last approximately through September 2022.

Primary focus of this position is to lead EU-MDR submission of products, including product gap assessments, planning and remediation of gaps within project timelines. Successful candidates will assist in developing, optimizing, and validating components/elements of a medical device, write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support test method development and validation, support other activities from R&D, Quality, Operations, and Regulatory Affairs.

Essential / Key Job Responsibilities (including supervisory and/or fiscal):
1.Support of EU-MDR submissions: leads all R&D activities surrounding EU-MDR submission of Oncology products, including kits and kit components.
2.Product Remediation: coordinates and/or leads all aspects of product remediation activity related to EU-MDR, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering. Works with cross-functional teams to remediate gaps related to EU-MDR requirements and meets all deliverables in line with division and business goals.
3.Project Management: creates, tracks and meets project schedules. Creates strategic plans and budgets for EU-MDR projects, assesses and manages priorities and leads task completion to ensure project objectives are met. Coordinates with team members, internal and external suppliers, and outside professionals to ensure project output meet business needs as well as applicable regulatory requirements.
4.Design to Manufacturing Transfer: proposes and facilitates product updates in line with EU-MDR requirements while maintaining design intent and smooth transfer to manufacturing.
5.Documentation: Prepares product development plans, leads and participates in design reviews, approves technical documents and reports. Reviews, approves and coordinates execution of verification and validation protocols and reports. Develops and implements department and division procedures/policy.
6.Test Method Development: leads the development of clinically relevant test methods that adequately challenge product design and processes.
7.Testing: Plan, develop, execute and manage verification and validation activities for products and processes in support of EU-MDR requirements.
8.Training: train technicians and engineers on design and process development and provide input to training of division procedures and policies.

Required Qualifications:
•B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering Bachelor's Degree preferred.
•Experience: 4-7 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 1-3 years medical device or equivalent industry experience).
•Demonstrated hands-on technical aptitude.
•Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
•Ability to create and execute project plans.
•Ability to lead cross functional teams.
•Basic tooling, design and drafting knowledge.
•Excellent oral and written communication skills.
•Ability to analyze data, interpret results, and write reports. Proficient in statistic software.
•Training in Six Sigma or Design for Six Sigma.

Preferred Qualifications:
•Masters degree in relevant engineering discipline.
•Knowledge of cGMP and GLP is a plus.

Education and/or Experience:
•B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering Bachelor's Degree preferred.
•Experience: 4-7 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 1-3 years medical device or equivalent industry experience).

Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case observations.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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