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: Position Summary: We are recruiting for a R&D Engineer II to join our team in St. Paul, MN. This is a unique opportunity to join an early-stage development team that provides solutions to patients suffering from mitral valve disease. The position is on a fast-paced, early product development team within Abbott's Ventures Organization. The individual who fills this role will play a pivotal part in the design, development and testing of this novel trans-septal prosthetic tissue mitral valve from early clinical feasibility through commercialization. Candidate will be responsible for providing engineering support in the creation and the development of new medical device products (invasive and non-invasive). Primary Responsibilities: Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment Conducts feasibility studies to verify capability and functionality Develops new concepts from initial design to market release Maintains detailed documentation throughout all phases of research and development Investigates and evaluates existing technologies Reviews or coordinates vendor activities to support development Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors Work with internal departments and outside vendors to obtain prototype parts Under the guidance from a Senior Engineer, generate design improvement concepts to meet specific design goals Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Required Qualifications: Bachelor's Degree in Mechanical, Chemical, or Bio-Medical Engineering 2+ years' experience in an engineering environment (i.e. manufacturing, R&D, or lab setting environment) Demonstrated experience writing test methods, model development and identifying potential issues with designs Experience using ProE or Solidworks. Ability to work well independently and as a member of a team is essential. Preferred Qualifications: MBA Hands-on experience with transcatheter heart valve design and the proven ability to apply technical knowledge and judgment to complex technical problems and technical proficiency specific to mechanical problem solving in medical device design. Experience in new product development with successful design from concept to commercialization
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: Summary: As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level, participating in cross-functional teams. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide. In this role, the regulatory affairs specialist will provide global regulatory support for Abbott Vascular's medical device products , which may include regulatory submissions, existing product maintenance and new product development. Qualifications: This position does not require previous regulatory experience, but it is strongly preferred. 2-3 years experience in a regulated industry (e.g., medical devices, pharmaceuticals) is required. Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience. Additional Knowledge and Responsibilities: Regulatory history, guidelines, policies, standards, practices, requirements and precedents. Regulatory agency structure, processes and key personnel. Principles and requirements of applicable product laws. Submission/registration types and requirements GxPs (GCPs, GLPs, GMPs). Principles and requirements of promotion, advertising and labeling. Domestic and international regulatory guidelines, policies and regulations. Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position. Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents. Work with cross-functional teams. Work with people from various disciplines and cultures. Write and edit technical document.s Negotiate internally. Pay strong attention to detail. Manage projects. Create project plans and timelines. Think analytically and critically. Organize and track complex information. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on the business. Apply business and regulatory ethical standards.
Sylmar, Los Angeles, CA, USA
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. Provides for and delivers health care services to workers and worker populations within an occupational setting to assist ill and injured employees to reach maximum health and productivity. Functions as a clinical case manager and coordinates an individual client's health care services across multiple systems from the onset of injury or illness to a safe return to work or an optimal alternative. Care is coordinated with a focus on achieving quality care delivered in a cost-effective manner. Using a unique knowledge of employees, their social or family system, and the work environment, the occupational health nurse assesses, plans, implements, coordinates, monitors, and evaluates the care for clients. Practices within the parameters of professional licensure to ensure consistency with legal, labor, regulatory and corporate requirements. **Responsibilities:** + Collaborates with management and the broad Environmental, Health and Safety staff to carry out mutual corporate objectives. + Acts as a professional health resource for the organization's management in planning and maintaining initiatives and programs that meet defined goals and objectives. + Provides initial assessment of occupational injuries, illnesses and exposures and may treat or refer for further evaluation as necessary in accordance with clinical guidelines and protocols. + Assesses the broad spectrum of client needs, including physical and psychosocial factors, using data from various sources including, but not limited to aggregate case/claims experience, employer representatives, other health care providers, health records, and third-party representatives. + Assesses non-occupational sudden illnesses occurring at work, determines the immediacy of treatment, and gives guidance to seek care from emergency/personal health care providers. + Develops a plan of nursing care based on identified needs and problems and assists with the development of primary, secondary and tertiary prevention and health promotion strategies to optimize health and prevent injuries and illnesses. + Develops processes for identifying situations that require early intervention to maximize desired outcomes. + Identifies client goals, objectives, and actions in a comprehensive case management plan and implements interventions to achieve desired outcomes within designated time frames. + Coordinates nursing process to generate consistent documentation of treatment, interactive process and administrative aspects. + Establishes generic and specific communication plans involving internal and external parties, as appropriate. + Identifies qualifications and expectations for, and monitors and evaluates outcomes and quality of services delivered by health care providers and vendors in the treatment and rehabilitation network. + Collaborates with treatment, rehabilitation providers, third party representatives to coordinate/provide for the appropriate care, treatment and follow-up of work related health events based on knowledge of the specific work environment for optimal outcomes. + Assists supervisors and employees with return to work issues including work restrictions, modified scheduling and job accommodations. + Provides health-related counseling for supervisors and employees within the scope of nursing knowledge and practice. + Conducts workplace walkthroughs/assessments and exposure follow-up. + Maintains and safeguards privacy and confidentiality of business and protected health information. + Participates in the development of related policies, procedures and work instructions. + Identifies re-searchable problems and participates in studies and projects according to research skills. + Assumes responsibility for professional development and continuing education to ensure competency and performance consistent with professional Occupational Health Nursing standards. + May demonstrate basic project management skills by acting as a project lead on small, well defined projects. + Independently resolves issues, elevating only the most complex situations to the Occupational Health Manager ,Clinical Services as indicated. + Broad operating latitude. Serves as an occupational and environmental health and safety expert to the corporation, community, and other outside groups. + Encourages, supports and actively contributes to the team. + Willingly shares expertise and experience with others; is considered a subject matter expert. + Creates role-appropriate plans, actions steps, and timetables to support the strategy, goals and assignments. + Influence exerted at peer level and occasionally at first levels of management. + Plans, organizes, and prioritizes own daily work routine to meet established schedule. + Exercises authority and judgment within defined limits to determine appropriate action. + Failure to achieve results or erroneous decisions or recommendations may cause delays and may result in the allocation of additional resources. **Qualification:** + Registered Professional Nurse with current State license to practice. + Bachelor's degree plus minimum 3-5 years' experience in Occupational Health or Community Health (Hospital, Emergency Room, etc.) + Excelled verbal and written communication skills, solid knowledge of Occupational Health, and excellent computer skills required. + The ability to perform independently, interact well with all levels of employees and make well-informed decisions is required. + Detailed knowledge of OSHA and other federal regulations that govern the workplace. + Detailed knowledge of Worker's Compensation regulations. + Working knowledge and application of business concepts, procedures and practices. + Will perform this job in a quality system environment. + Failure to adequately perform tasks can result in noncompliance with governmental regulations. + Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. + Exercises judgment within defined procedures and practices to determine appropriate action. + Has a general knowledge of technical alternatives and an understanding of their impact on the systems environment. + Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks. + Occupational Health nursing experience preferred. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call or email