Champion and manage through completion, complex technical infusion pumps and software development projects using advanced techniques and serves as a technical expert. Defines business technical/patent strategy. Analyzes, evaluates and plans solutions for increasingly complex software development projects.
Essential Duties & Responsibilities
Act as the Lead Systems Engineer infusion pump platform
Act as the Subject Matter Expert for infusion pump platforms within the Systems Engineering team
Develops scope, plan and direction for programs/projects integrating multiple technical functions. Communicates with business unit/corporate and other professional experts to achieve company goals. Assignments are often long-term and self-directed.
Supervises the work of exempt and non-exempt hardware system engineers. Responsible for training/mentoring less-experienced engineers. Responsible for the performance evaluations of all reports. Resolves complex problems within teams, departments, projects, programs and cross-functionally. Manages activities of reports to achieve goals consistent with area, department, R&D and business unit objectives.
Conducts investigations of considerable complexity pertaining to the development of new designs, methods, materials or processes, and investigates possible applications of the results.
Establishes priorities and a course of action to achieve objectives; executes plans and achieves milestones: Integrates multiple project plans. Establishes and reviews complex plans for multiple activities/projects or plans highly complex personal projects; monitors and takes corrective action for processes and systems.
Can quickly find common ground and solve problems for the good of all and is seen as a cooperative team player. Encourages collaboration.
Contributes in a significant and ongoing way to programs that impact the business unit's competitive edge. May be responsible for directing assigned engineering and support staff.
Applies techniques to interpret/evaluate requirements, synthesize and evaluate data and draw conclusions: Creates theoretical models. Investigates new analytical approaches/technologies and creates innovative theoretical models to develop solutions to complex problems.
Technical advisor to site and business unit management.
Translates changes in business goals and objectives into the skills, knowledge and experience needed for future work.
Perform other related duties as assigned or required.
Work on special projects as they arise.
Knowledge, Skills & Qualifications
Well-developed ability to lead direct and indirect reports in a cross functional and multi country environment
Experience with electronic, power and battery, and electro-mechanical subsystems for medical devices
Experience with developing product requirements and design inputs; experience with Sysml tools is a plus
Experience with requirements management tools such as Magic Draw and DOORS is a plus
Experience with applicable global regulatory standards associated with medical devices
Experience building Risk Management Files per ISO 14971
Experience with on-market issue risk assessment
Experience owning and managing CAPA investigations
Experience developing various medical device products
Excellent oral and written communication and presentation skill to accomplish business goals and to foster and improve productivity
Education and Experience
Bachelor's in Computer Science, Electrical Engineering or related degree from an accredited college or university is required
Master's Degree is preferred
Minimum of 10 years' experience in software development including 3 years leading teams. MS preferred.
Must be at least 18 years of age
Must pass pre-employment drug screen and background check
Physical Requirements and Work Environment
This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
10% travel in US and out of US.
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.