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Mallinckrodt Pharmaceuticals Systems Engineering Manager in United States

Job Title

Systems Engineering Manager

Requisition

JR000011539 Systems Engineering Manager (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Job Description

Summary

Systems Engineering is an engineering discipline focused on creating and executing an interdisciplinary process to ensure that the customer and stakeholder's needs are satisfied in a high quality, trustworthy, cost-efficient and schedule-compliant manner throughout a system's entire life cycle

Leads a team of System Architects, with direct reports consisting of MNK employees and contractors, for a portfolio of projects. This Systems Engineering Manager will work closely with the VP GDE as well as Brand team and technical functional managers to ensure the outline system requirements identified during the concept phase of the project are understood and transferred into the planning phase.

Essential Functions

  • Ensures consistency and incorporates best demonstrated practices through example of his systems engineer team throughout planning and development phases, are leading the requirements development, product definition, systems level architecture design and external communications/connectivity interface designs by collaborating with cross-functional disciplines within and outside GDE.

  • Understands the business needs of the company and has a thorough knowledge of the customer and clinical needs when developing a project scope. Stays abreast of and lends foresight to the incorporation of emerging technologies.

  • Conceptualizes complete solutions. Creates or coordinates the design solutions for novel or complex problems; works with programme core team members including Quality and Regulatory to ensure conformance to established design development processes and procedures

  • Works with the various engineering disciplines to translate market-driven requirements into technical specifications, and ultimately flow them down into lower level hardware and firmware requirements documents.

  • Explores multiple alternatives. Structures studies and integrates cross-disciplinary (Software, Electrical, Mechanical) and cross-functional issues to arrive at a solution, e.g., investigates process to meet increasing regulatory requirements while maintaining serviceability & manufacturability.

  • Works with program managers to help create project schedules. Leads and facilitates architectural and design decisions to ensure on-time delivery of projects. Escalates technical issues in a timely fashion to R&D leadership.

  • Interacts with both senior management and external personnel on significant technical matters often requiring coordination between organizations.

  • Prepares written communication. Conveys information effectively through formal and informal documents, e.g., develops proposals, project summaries, and design documentation; submits articles for internal or external publication.

  • Generates system architecture documentation and reviews/approves electrical, mechanical, software architecture and subsystem architecture documents.

  • Is identified as a Subject Matter Expert in the structural/architectural disciplines. Participates in internal, cross-divisional teams to develop and align procedures and standards.

  • Functions well in a team environment. Gains consensus, leads, influences and ensures cross-discipline participation and feedback.

  • Provides mentoring in technical and organizational areas across multiple work groups; monitors the improvement of other engineer(s), e.g. delegates challenging tasks to others to help them develop; provides constructive and timely feedback.

  • Participates in the evaluation of assigned staff/project team members and in the identification of development needs.

  • Responsible for developing System Interface Documents linking sub systems

  • Application of best practice in requirements definition and management.

  • Familiarity with requirements management tools (e.g., DOORS, Polarion, Jama), as well as modelling-based systems engineering tools (e.g., Enterprise Architect, IBM Rhapsody) preferable.

GDE Manager Level Shared Competencies

  • An engineering professional who, working with little or no supervision, applies advanced scientific knowledge, engineering knowledge, mathematics and ingenuity to complete complex assignments related to a specific technical field or discipline.

  • Is a resource for junior team members in the development and execution of strategic solutions.

  • Provides strategic communication resulting in consensus and conflict resolution.

  • Actively seeks ideas from team members; persuades the cross functional team to implement the best options.

  • Proactively identifies and understands issues, problems, and opportunities of team members and leadership

  • Sought out as a Expert with knowledge of medical Device Development Standards discipline specific (ME, SW, EE, Ver or Val) standards (i.e. 60601-1-1, IEC 62304, etc.).

  • Application of Medical Device Standards: FDA 21 CFR Part 820. FDA Quality System Regulation, ISO 13485:2016 ISO Medical Devices Quality Management System, ISO14971:2019 Medical Devices.

  • Application of Risk Management process in to design and business decisions

  • Remaining current of any new or proposed regulations and understanding impact and anticipating changes required with organization to stay compliant

  • Analyzes complex interdisciplinary problems and identifies their impact.

  • Establishes methods/designs/processes. Identified by others as an expert problem solving techniques.

  • Mentors others by sharing technical expertise and providing feedback and guidance

  • Manages multiple, often concurrent, projects and meets deadlines. Establishes workable and trackable schedules.

  • Works with staff, outside firms and/or consultants to agree on plans and timetables for a specific project; identifies pinch points or conflicts,

Education / Experience / Skills:

  • BS or MS degree in a scientific or engineering discipline

  • 10+ years Systems Engineering Experience of complex Electrical/Mechanical products

  • 5+ years Medical Device Development Experience

  • Accreditation by/familiarity with INCOSE (International Council on Systems Engineering) and associated guidelines a distinct advantage

  • Familiarity with requirements management tools (e.g., DOORS, Polarion, Jama), as well as modelling-based systems engineering tools (e.g., Enterprise Architect, IBM Rhapsody) preferable.

Organizational Relationship/Scope:

Leadership role reporting to the VP GDE with a team of direct reports (FTE’s & contractors). Requirement to partner and work with functional managers within GDE and the broader stakeholder organisations including the brand team.

Working Conditions:

Office based role, with occasional requirement to travel.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

#LI-CL1

Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.

To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.

Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.

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