The Sr. Software Engineer is responsible for designing and implementing product enhancements and developing subsystems or engineering components of major projects. Assignments are broad in nature, usually requiring appreciable initiative, originality, and ingenuity. Coordinates design activities, reviews and reports design’s progress, and evaluates results.
Essential Job Functions:
- As part of product development team, perform one or more of the following duties as assigned by Product Development Manager to support the team’s goals.
- Responsible for design/development activities which may include leading, participating, or supporting:
- Concept, planning, design and execution stages
- Risk assessment
- Pilot Production
- Design reviews
- Manual creation
- Verification & Validation
- Serve as technical leader for major development projects or multiple simultaneous projects. Responsible for ensuring that design activities are coordinated per the development procedure. Establish and maintain project schedules.
- Coordinate with project team to create and release Product Requirements, Design Specifications and Design Descriptions for assigned designs applicable standards and procedures. Responsible for recording and sharing technical knowledge gained with colleagues.
- Participate in the all phases of design on singular projects; investigate interchangeability, replacement, cost factors, and ease of manufacture. Work with all Project team members throughout the development phase of product development in order to ensure that products are produced in a safe and quality manner while keeping within established time frames.
- Responsible for design and development of mechanical/electromechanical systems or electrical hardware or embedded/pc-based software. Responsible for ensuring that design activities are coordinated per the development procedure.
- Establish and maintain project schedules.
- Works on significant and unique analysis of situations or data requiring an evaluation of intangibles. Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results.
- Contacts pertain to significant matters often involving coordination among groups.
- Prepare technical reports.
- Research design options and perform experiments to determine potential design feasibility or application.
- Responsible for design and development of mechanical/electromechanical systems or electrical hardware or embedded/pc-based software.
- Assess design and development activities to determine time for completion and appropriate staffing and/or use of outside resources to reach goals.
- Work with other departments within the company to optimize production, diagnostics, and repair activities.
- Review product documentation for accuracy including documentation intended for customer use.
- Evaluate product non-conformances and recommend design modifications.
- Evaluate, test, and review designs to determine if program will perform according to requirements and specifications.
- Mentor other engineers and technicians.
- Develop, communicate and document project strategies and plans.
- Maintain accurate records throughout the development process in order to comply with company and government standards and/or regulations.
Required Education & Experience:
- Bachelors Degree in Engineering, Biotechnology, Computer Science, Engineering Technology or equivalent technical degree; or equivalent combination of education and experience.
- 7+ years related engineering experience.
Required Knowledge, Skills & Abilities:
- Familiarity with essential requirements of the Medical Devices Directive (MDD).
- Software: Experience with assembly-level and C code development, real time signal processing, and I/O control.
- Mechanical: Experience with Pro-E and AutoCAD.
- Self-Starter; Highly-Organized; Detail-Oriented; Highly-Motivated; Team Player; Analytical; Strong Interpersonal & Verbal/Written Communication;
- Customer-Focused; Results-Driven; Initiative; “Can-Do” Attitude
- Strong background in development of microprocessor controlled hardware.
- Software development experience in an embedded environment for medical devices.
- Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
- Demonstrated experience in successful project management.
- Ability to sit, stand, and/or walk for 8 hrs/day.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.