System Engineer

Siemens Healthineers Point of Care Diagnostics Business line is a ~$800M leading provider of handheld and desktop analyzers and consumables, serving the blood gas, cardiac, urinalysis and diabetes care markets globally.  We are part of the Diagnostics business area that, combined with our Imaging, Advanced Therapies and Varian business areas, make up Siemens Healthineers, a $20B world leader in medical diagnostics and therapy.

As a leading global healthcare company, we at Siemens Healthineers develop innovations that support better patient outcomes with greater efficiencies, giving providers the confidence, they need to meet the clinical, operational, and financial challenges of a changing healthcare landscape. As a leader in medical imaging, laboratory diagnostics, and healthcare information technology, we have a keen understanding of the entire patient care continuum – from prevention and early detection to diagnosis and treatment. 

For more than 100 years, Siemens Healthineers in USA has helped healthcare providers achieve their goal of improving outcomes while reducing costs. From the Atlantic to Pacific oceans, more than 750 employees in USA work together to deliver solutions for healthcare providers, resulting in 70% of medical decisions being influenced by the technologies we provide.

More information is available at: www.siemens-healthineers.usa

Reporting directly to Senior Director Engineering & Maintenance; the Manufacturing Staff System Engineer, is responsible for leading the mechanical design & development of new production lines, implementation of Process Design and Sustaining Engineering principles, development & continuous improvement of all automated Production lines, new project implementation, testing & validations, maintenance in meeting Mishawaka POC SCM’s Mandate for the Urinalysis + Novus, DCA and VTLi products, as well as assisting in all areas of the maintenance of hardware equipment and automations & transformation to achieve the highest level of Operational Excellence.

Duties and Responsibilities

Key Responsibilities

Will be responsible for the design space characterization, integration, and verification of the system of complex manufacturing production line and for new improvement / development projects; In this capacity, this position is responsible for providing technical expertise in mechanical designs and development of existing production line, improve overall efficiencies of the Automated Production lines, collaborate with process controls team, machinists, electricians, and Solutions Engineering Team for manufacturing of consumables of medical devices in a highly automated and regulated medical device manufacturing environment; manage multiple projects that cover existing manufacturing lines upgrades, new manufacturing lines design, continuous improvement, interactions with suppliers and cross-functional collaborations within Engineering & Maintenance Team, Operations, Quality, Tech Ops, Material Management, R&D department and other POC SCM Sites.

• Work closely with cross-functional design team members to ensure that the full understanding of Production lines and its various subsystem/system functionality and performance is developed.

• Drive the development of systems design concepts to meet manufacturing / Production Line performance requirements.

• Develop expertise in the interaction between different elements of detailed design, give unique insight to the potential for emergent behavior and weigh merits of various design concepts against each other.

• Oversee, plan and execute experiments to study design feasibility, and identify & characterize critical design parameters and their boundaries.

• Develops projects to increase the overall productivity of all manufacturing lines.

• Develop reliability plans and xFMEA for production systems to maximize availability.

• Identify solutions to complex technical issues by troubleshooting, determining root cause, and then proposing design modifications.

• Support conduction plant simulations to optimize resources and cycle time during the development of new product lines as well as in the operational phase.

• Support the development of cost effective automation solutions and provide guidance on the integration of production systems, aligning them with functional requirements and budget goals.

• Participates in audit support and functions as a process owner during audits.

• Collaborates with other teams in support of new product launches through process design, development, and transfer of new products to production.

• Reviews assigned CAPA’s and non-conformances pertaining to the manufacturing process and equipment.

• Compliance with ISO, FDA, and all applicable medical device regulations related to medical device manufacturing.

• Provide systems instrument technical guidance and knowledge transfer to internal fleet support /Services teams when escalated by Level 1 Engineers.

• Analyze system & performance test data and establish acceptance criteria.

• Anticipate potential problems that may impact system performance and develop risk mitigation plans.

• Write & review data-driven technical summaries and test reports.

• Assure compliance to all design characterization, integration and verification quality procedures and policies of product development.

• Communicate project plans and status to a wide stakeholder community -- up, across and down through the organization.

• Develop a foundational technical knowledge base of the MSH product/system manufacturing processes to ensure efficient and effective contribution and engagement with the team.

• Oversee procedures pertaining to:

o Mechanical / system design characterization of Production line.

o Engineering prototype configuration management during system verification

o Design verification and traceability.

o Technical and Product Risk Management

o Design transfer to manufacturing.

o Manufacturing /Quality Control Systems support.

Note: Duties are not limited to those listed above. Additional duties may be assigned as required. However, reasonable accommodations will be made if all possible under business conditions.

Key Contacts

• Reports directly to Head/ Senior Director Engineering & Maintenance, Mishawaka.

• Regular interaction with other managers within Engineering Team, Operators, Supervisors, Stores, Procurement, Tech Ops Team, R&D team, Quality Team, OEM partners and Vendors.

Job Demands

• Demonstrated systems and design engineering experience in complex electromechanical instrumentation in a new product development R&D environment.

• Experience with medical device product lifecycle preferred, working knowledge of medical device systems including optics, mechanical, electrical, fluidics and software components.

• Familiar with modern design methodologies and associated tools.

• Experience with supplier management (Automation and contract manufacturing).

• Full understanding on validations and qualifications in highly regulated environments.

• Knowledge in martials science (Plastic, Precision Molding, and Tooling).

• Experience with full factory automation (desired) including ICS (Industrial controls systems).

• Experience with high throughput manufacturing systems and continuous operation environment is desired.

• Excellent verbal and written communications skills.

• Experience working with large cross organizational multidisciplinary teams, while satisfying individual responsibilities and objectives.

• Excellent project management skills with strong attention to detail and accuracy.

• Strong knowledge of Agile product development.

• Willingness to travel and flexibility is expected as part of OEM development, project validations, FAT, etc.

• Must be self-driven and highly motivated.

• You have adept knowledge in IT environments and strong computer skills. 

• You have very good presentation and mentoring skills; therefore you will be providing training to maintenance engineers, skilled trades, production and engineering staff in the setup, use and maintenance of manufacturing assembly systems.

• An extremely involved level of cross-departmental coordination, consultation and reconciliation of varied input and opinions.

• Self-starter and can work independently on projects as required.

• Successful demonstration of delivering results, technical expertise, problem solving, training, recruiting, influencing, initiative and quality decision-making..

Skills & Qualifications (Education and Experience)

• University Degree in Engineering required. Masters in a related field is desirable and/or an equivalent combination of education and technical and industrial experience acceptable to Siemens Healthineers.

• 7 or more years of industrial experience preferably in medical devices

• Minimum of 5 years in an ISO regulated industrial environment (preferred).