Job Scope and Quality Impact:
This position is responsible for the design, development and manufacturability of software related product(s)/system(s) in accordance with the company’s Quality System and customer requirements. This position complies with Quality System by engaging in appropriate levels of GMP/ISO test methodologies, adherence to Quality System Design Controls, and applies proper documentation skills.
General Description and Duties:
To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Software Engineering: Establishes functional requirements, deliverables, timelines, budgets and develops corporate status reports of projects/products. Works with project team to develop detail specifications, construction of prototypes, pre-clinical trials for new products or current product enhancements. Prepares and delivers status reports. Develops, sets up, and runs product testing and protocols in accordance with project plans. Recommends and/or selects vendor and material choices for product. Ensures product documentation is in accordance with Quality System requirements. Assists in the reaction and maintenance of software specifications. Participates in software risk hazard analyses. Complies with software validation requirements. Participates in appropriate test plans and reports for software verification and validation work as necessary. Provides for evolution of requirements, stress test coverage and maintain verification trace matrices. Performs software unit/integration testing, white box testing, and code inspections.
- Product Enhancements: Provides feedback to the development staff on client specific enhancements as well as new applications for base product. Acts independently to research design and develop new products and current product enhancements.
- Manufacturability: Designs new software or software enhancements in a cost effective and timely manner and with an understanding of how the product will be manufactured and used. Contributes to or leads the process of transferring product from development to manufacturing.
- Sales: Participates in customer meetings, trade shows, etc. upon request. Keeps abreast of competition and trends in the field and market.
- Regulatory Acceptance: Provides engineering testing and documentation that is in accordance with regulatory requirements for approvals of products by the U.S. and foreign regulatory agencies.
- Intellectual Property: Works with senior staff and/or attorneys in writing and researching patents. Participates in and contributes to brainstorming sessions to generate new intellectual property.
- Safety: Performs job functions in a safe and effective manner. Helps ensure employees are adhering to the safety procedures of the company.
Projects and Other Duties:
- Perform other duties as assigned.
- Experience using oscilloscopes, logic analyzers, and other related tools.
- Experience working with domestic and international regulatory agencies. Knowledge of ISO 13485 and FDA QSR is desired.
- Strong project management and communication skills.
- Detail oriented and well organized.
- Bachelor’s degree in Computer Science, Computer Engineering, or other appropriate engineering science field.
- 2 years working on Class III medical device embedded software development, or software development or other highly regulated industry.
- For Senior Embedded Software Engineer, 5 years working on Class III medical device embedded software development or other highly regulated industry.
- 3 years programming and test on complex software systems.
Specific Skills, Knowledge & Behaviors
(To perform the job successfully, an individual should demonstrate the following competencies)
Supervisor Core Competencies:
- Leading Change: Develops and implements strategies and approaches for leading and managing organizational transformation at individual, functional, and enterprise levels, and influences change where needed
- Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results
- Selecting & Developing Talent: Assesses, selects, coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels
- Strategic thinking: Creates the vision and direction, assesses priorities, understands, analyzes, and acts upon drivers of business and operational success at a departmental, functional, and/or enterprise level
- External Industry Leadership & Knowledge: Connects with and influences health care and/or functional industry regulatory and government organizations, and understands external industry factors that impact the company and products
- Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self-awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately
- Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
- Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
- Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
- Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
- Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self
- Problem Solving & Problem Prevention: Learns and uses strong problem- solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
- Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
Equipment Use & Abilities Required:
- Equipment Use: Copy machines, fax machines, calculators and personal computers and computer terminals.
- Computer Skills: Software proficiency in Microsoft Office Suite.
- Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:
The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.