Sr. Systems Engineer

hace 5 días

Buenos Aires, Buenos Aires C.F., Argentina IMRIS, Deerfield Imaging A tiempo completo

OVERVIEW

As a leader in image guidance solutions, IMRIS, Deerfield Imaging provides optimized, fully integrated image-guided therapy environments that address the important needs of patients, clinicians, and hospitals by delivering timely MRI and imaging data to clinicians for use during surgical or interventional procedures. The IMRIS Surgical Theatre enables intraoperative imaging directly within operating rooms. The Company also designs and manufactures proprietary head fixation devices, imaging coils and OR tables for use in this unique and multifunctional intraoperative environment. It is estimated that over 70,000 patients have benefited from lifesaving or life-extending procedures performed in an IMRIS Surgical Theatre. IMRIS will continue to integrate new intraoperative imaging technologies and shape the future of neurosurgery in operating rooms worldwide.

We are currently searching for a Sr. Systems Engineer (RPE) to join our Released Product Engineering Team. This role will be performed both on-site and remotely as necessary, but is based in the Greater Twin Cities area at our Chaska, MN headquarters. Please note: There is no relocation offered for this role. The ideal candidate should reside in the Greater Twin Cities area.

JOB SUMMARY

The Sr. Systems Engineer (RPE) leads systems engineering activities for durable Class II medical devices, focusing on released product. This role is responsible for requirements management, system architecture evolution, risk management, and verification & validation (V&V) activities. The Sr. Systems Engineer (RPE) serves as a systems engineering representative and technical lead on one or more cross-functional development teams, and as the project lead for small development projects and CAPAs.

The Sr. Systems Engineer (RPE) performs systems engineering for product sustaining activities, including risk assessments and requirements review for complaint investigations, Health Hazard Evaluations and enhancement requests for existing products. The Sr. Systems Engineer (RPE) works to develop the knowledge and skills to become a subject matter expert on multiple MRI Surgical Suite related products and may support customer service teams in the field, as needed. Travel is not required, but occasional opportunities may arise.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  1. Lead systems engineering activities focused on released products
  2. Facilitate cross-functional team discussions related to system requirements, system functional decomposition, requirements allocation, system architecture definition, system modeling, and requirements traceability and compliance
  3. Provide risk and requirements impact assessments to support complaint investigations, Health Hazard Evaluations and enhancement requests for our existing products
  4. Lead engineering change and CAPA projects by applying defined risk assessment framework to identify risks, assess risks, develop mitigations and translate the mitigations to requirement
  5. Responsible for leading and conducting verification and validation test planning and execution for assigned projects, including protocol and test case development, testing oversight, test results analysis and test conclusions
  6. Define product requirements and testing to comply with global regulatory requirements
  7. Work cross functionally to understand and address field or production issues as they arise
  8. Lead design input and design output reviews to assure appropriate product definition and final product function
  9. Act as a subject matter expert for one or more existing products and own the related requirements and risk filesLead small to medium size engineering projects that include cross functional team members

SUPERVISION RECEIVED AND EXERCISED

  1. Reports to the Sr. Released Product Engineering Manager

KNOWLEDGE, SKILLS, AND ABILITIES REQUIREMENTS

Education and Work Experience

  1. Minimum of BS in relevant engineering discipline
  2. 5+ years of systems engineering experience in the medical device industry (optimally for durable Class II medical equipment with a focus on electro-mechanical systems)

Abilities

  1. Ability to apply systems engineering methodology to complex electro-mechanical systems.
  2. Understanding of and experience with requirements management, including requirements definition and flow.
  3. Experience in verification and validation planning and execution for design changes, including test plan and test protocol development
  4. Experience in structured risk management methodology in compliance to ISO 14971, including hazards analysis and FMEA
  5. Experience with risk assessment for complaints and Health Hazard Evaluation
  6. Experience with Usability Engineering in compliance with IEC 62366, ANSI/AAMI HE75
  7. Experience in structured investigation and problem solving techniques for root cause analysis
  8. Proficient in generating system/subsystem specifications, use-case scenarios and interface control documents
  9. Proficient writing skills for documenting engineering conclusions and creating/updating Engineering Change Orders, Risk Management File, and Requirements Documents
  10. Detailed knowledge of relevant regulatory requirements and standards, including EU MDR, ISO 13485, IEC 60601, 21 CFR Part 820 (QMSR), ISO 14971

Preferred

  1. EU MDR experience
  2. Proven project management/leadership capabilities
  3. Proficiency with JAMA for requirements management and traceability
  4. MS in Systems Engineering or INCOSE Certification
  5. Experience leading Corrective and Preventive Action (CAPA) projects
  6. Experience providing systems engineering support to Production and Customer Service functions
  7. Knowledge of advanced needs & requirements definition methods such as use case behavioral diagramming, quality function deployment
  8. Experience in system and subsystem verification testing of low volume medical devices
  9. Experience and understanding of MRI functionality and workflows
  10. Ability to mentor and support junior level systems engineers

IMRIS offers a competitive & comprehensive benefits package that includes:

  1. Health Insurance
  2. Dental Insurance
  3. 401(k) savings plus matching
  4. Flexible Spending Account
  5. Life Insurance
  6. Disability Insurance
  7. Vision Insurance
  8. Generous PTO
  9. Incentive bonus
  10. Paid Parental Leave

Compensation Disclaimer
The actual rate of pay offered within this range may depend on several factors, such as skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization values pay equity and considers the internal equity of our team when making any offer. Hiring at the maximum of the range is not typical.

Visit our website: www.imris.com

Visit our youtube channel: http://www.youtube.com/user/imrisinc

Follow us on Twitter: @imris_inc

IMRIS is an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, age, pregnancy, national origin, physical or mental disability, genetics, sexual orientation, gender identity, veteran status, or any other legally-protected status.

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