Principal Engineer Product Development

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

Use multidisciplinary engineering knowledge to design and develop innovative single use electrophysiology catheters and/or introducers/sheaths  in support of company’s strategic plan. In addition to general device design responsibilities, this role specifically will be focused on the development of device handle component and assembly design. Role will require providing work direction to other engineers and team members in order to complete project level deliverables.

MAIN RESPONSIBILITIES

• Design devices to meet user needs.  Establish requirements and specifications for these devices (including justifications and supportive testing)
• Establish site wide technical competence in specific areas.
• Use empirical, numerical and experimental analysis to evaluate designs. Lead test method and model development.  Develop site standards.
• Identify and mitigate project and site product line risks.
• Prepare and submit invention disclosures and steer investigations into promising areas
• Work with internal departments and external vendors to obtain prototypes and to expand these groups capabilities
• Lead Pre-clinical and clinical testing of devices
• Lead design reviews and physician visits. Develop relationships with key physicians
• Provide site technical leadership based on a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
• Maintain a detailed understanding of the quality and regulatory requirements of SJM, FDA and ISO regulation.  Provide input into shaping SJM quality and regulatory requirements
• Work with Project management to develop overall project schedules.  Manage time and tasks within schedule
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

QUALIFICATIONS

Education

Bachelors Degree (± 16 years)

Technical field, preferably mechanical, , biomedical, or management.

Or

an equivalent combination of education and work experience

Preferred

Masters Degree (± 18 years)

Technical or business field is preferred.

Experience/Background

Minimum 10 years:

• Medical device development and/or other highly regulated industry.
• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.  Ability to work within a team and as an individual contributor in a fast-paced, changing environment.  Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 25%, including internationally.

JOB FAMILY:

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