This position provides technical leadership in support of design improvements or changes necessary for sustained production of medical devices.  The position plays a key role in leading teams through the development and FDA compliance issues involved with medical devices. The position requires the development of an understanding of the current medical device markets and customer requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following.  Other duties may be assigned.

• Leading development & execution of R&D projects and programs, through all the phases & stage gates for successful commercialization of Class 1, 2 & 3 medical devices.

• Direct responsibility for project scope, schedule & budget to balance business deliverables within resource and time constraints.

• Coordinates communication across multiple functions and manufacturing facilities to review and prioritize projects.

• Ensure that projects are launched on time and meet established goals and objectives that support the financial and competitive goals of the organization.

• Provides the communication link between the project teams and Senior management team and other stakeholders.

• Actively identifying & managing project risk and ensuring adherence to established processes and methodologies.

• Ensure Design Control requirements are met for the project and is responsible for Design History File.

QUALIFICATIONS

An individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Detail oriented and ability to organize large amounts of work and data.  This includes the need for good documentation practices.

• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, influencing, and team building.

• Strong listening and assessment skills.

• Strong questioning & problem-solving skills.

• Proficient in the use of a personal computer with intermediate level of keyboarding skills and proficiency in Microsoft Word, Microsoft Excel, Microsoft Power Point, Microsoft Project, Microsoft Access.

• Spanish is a plus.

EDUCATION and/or EXPERIENCE

• BS Degree in Engineering, Sciences or equivalent

• 4+ years proven experience in medical device industry

• Demonstrated success as a project manager, leading NPD/SE projects, and launching innovative medical products

• Experienced in Risk Management and contingency planning.

• Proven track record to lead projects involving resources in multiple locations

• knowledge of FDA and ISO medical device development regulations

• Project Management Professional (PMP) Certification preferred

• Proficient with Microsoft Office Suite Project Management software

• Innovative, Self-motivated and Results driven

• Excellent Interpersonal skills

• Good oral and written communication, including reports and business correspondence

• Ability to travel up to 25%

• Manufacturing experience is a plus.

LOCATION

• Covington, GA

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Required Skills

Optional Skills

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