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:
Leads the team of Software and System Quality Engineers to support New Product Development for diagnostic imaging and physiology medical device systems including design, development, manufacturing and supplier controls processes. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.
- Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
- Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
- Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
- Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
- Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
- Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
- Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
- Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
- Translates department goals into individual objectives and KRAs.
- Identifies, develops and implements processes to improve department performance.
- Monitors departmental activities and records to ensure compliance independent action through critical decision making.
- Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
- May also direct work assignments for quality control auditors.
- Directs Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
- Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
- Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
- Expertise in the following areas is desired:
Software development life cycle for medical devices - ISO 62304
Agile Software Development Lifecycle model
Risk Management for Medical Devices - ISO 14971
Design Controls specifically for complex software electromechanical devices
Experience with machine learning
Electrical safety specifically the family of IEC60601 standards
Laser safety IEC 60825
Usability and human factors engineering
JIRA and / JAMA suite of requirement management and software change tracking systems
Bachelor'sdegreeand9+yearsofrelatedworkexperienceoranequivalentcombinationofeducation and workexperience.Advanceddegreepreferred.
* Design/development of capital hardware
* Risk management experience
* Reliability experience
* Software experience a plus
• Promotes the attainment of group goals by selecting, motivating, and training capable staff;
• Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives
• Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability;
• Carries out operations within an established budget.
• Assignments are expressed in the form of tasks and objectives;
• Generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management;
• Consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.
Technical/Business Knowledge (Job Skills): Monitors progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
Cognitive Skills: Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit. JOB FAMILY:
Operations Quality DIVISION:
AVD Vascular LOCATION:
United States > Massachusetts > Westford : 4 Robbins Road ADDITIONAL LOCATIONS:WORK SHIFT:
Yes, 25 % of the Time MEDICAL SURVEILLANCE:
Yes SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf