Job Description
We are currently working with a Medical Device Company that are looking for a Systems Engineer.
You might be hungering for the chance to lead projects from concept through to manufacturing (not having somebody else take over certain parts), you might want more visibility at a senior level (first stage interview is with the CTO or maybe you are tired of doing minor modifications to the same device (this company works on a range of products and does work from concept) - this role offers all of the above.
Add to that the stability of a big company but the mindset of a start-up and they really have a lot to offer before we even discuss the excellent salary and benefits.
Sound interesting? Happy to schedule a call to talk you through it all.
SUMMARY
Primarily responsible for developing electro-mechanical systems and system architecture and its associated documentation per established quality system procedures. You will work with multi-disciplinary teams to meet product and project requirements, collaborating with engineers from a variety of companies and industries.
DUTIES AND RESPONSIBILITIES
- Responsible for creating and building internal requirement sets and assisting the customer in developing user requirements, when needed.
- Support developing the risk management plan and report.
- Assist in creation, review, and documentation of risk analyses.
- May assist development of a Hazard Analysis.
- Accountable for ensuring product verification and validation and ensuring traceability is met for all requirements.
- Coordinate and facilitate interdisciplinary technical discussions within project teams.
- Responsible for coordinating and documenting system level analysis including system modeling, algorithm development, simulations, and system architecture.
- Serve as the primary technical contact for customers on projects.
- Accountable for the technical project scope and effort.
- Participate in the efforts to identify and implement technology re-use.
- Perform and participate in technical design reviews during product realization.
- Assist in evaluating technical talent.
- Identify technical training and tools for the systems engineering team.
- Participate in the identification and protection of intellectual property.
QUALIFICATIONS
Education:
- Bachelor's degree in Computer Science or an Engineering discipline.
- Master's Degree in Engineering is a plus.
Experience & Skills:
- Five or more years of experience, preferable in the medical device field, in the discipline of systems engineering.
- Experience with system designs compliant with IEC 60601, ISO 13485, ISO/EN 14971, and IEC 62304 standards.
- Experience with requirements management tools is a plus.
- Experience with modeling tools (Matlab, Simulink, etc.) is a plus.
- Knowledge of FDA 510(k), PMA, and De Novo pre-market submission processes is a plus.
- Experience developing Class II and III medical devices is a plus.
COMPETENCIES
- Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
- Design - Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
- Project Management - Participate in the development of project plans; Participate in the coordination of projects; Communicates changes and progress; Assist in the completion of project team activities.
- Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
- Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
- Change Management - Participate in the development of implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance.
- Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment.
- Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
- While performing the duties of this job, the employee routinely is required to sit; walk; talk; hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, and stretch.
- The employee is occasionally required to move around the facility.
- The employee may occasionally lift and/or move up to 20 pounds.
- May require travel dependent on business needs (less than 10% travel on average).
- Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
- The environment generally is moderate in temperature and noise level.
- Must be able to read and interpret data, information, and documents.
- Can observe and respond to people and situations and interact with others encountered in the course of work.
- Can learn and apply new information or skills.
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