Job Title: Software Engineer
Department: Engineering
Reports To: Director R&D
Location: 144 Railroad Drive Ivyland PA, 18974
General Summary:
The Software Engineer position will be focused on the design and development of new and existing software for medical devices and the maintenance of the software throughout its full lifecycle. The position is responsible for writing technical documentation and working within a Quality Management System customary in the medical device industry.
Essential Functions:
· Must have knowledge and experience with object-oriented, back-end programming languages (Java, VB.NET, C#, etc.)
· Database management using SQL server software
· Experience with Windows 10 configuration, including Group Policy, security settings, and application management
· Knowledge of scripting languages such as PowerShell for automation tasks related to both SQL Server and Windows 1
· Must be analytical, have good problem solving skills, and work in a well-organized and structured manner
· Develop and maintain device software design history files
· Conduct post market cybersecurity threat assessments
· Respond to and remediate security incidents, including data breaches and unauthorized access
· Must be able to work within cross functional teams to create requirements, specifications, designs, test plans, etc. to ensure that software safely satisfies user requirements
· Perform other duties and tasks as assigned by management
· Previous experience in the design of FDA regulated medical device software systems is an advantage
Education Required:
· Must have a BS in Software Engineering, Computer Science, Computer Engineering.
Practical Experience:
· Must have at minimum 3 years’ of experience in software design and development
Aptitude Required:
· Mental: Constantly
· Mechanical: Occasionally
· Verbal: Frequently
· Personal Initiative: Very Important
Physical Requirements:
· Standing: Occasionally
· Walking: Occasionally
· Sitting: Frequently
· Bending/Stooping/Squatting: Rarely
· Climb Stairs: Rarely
· Lying Down: Rarely
· Push or Pull: Rarely
· Reach Above Shoulders: Rarely
· Climb Ladders: Rarely
· Grasp/Grip: Occasionally
· Finger Dexterity: Occasionally
· Writing/Typing: Frequently
· Driving/Operating Equipment: Rarely
· Vision (Beyond Arm’s Length): Rarely
Lifting/Carrying:
· Over 150 lbs: Rarely
· 76 – 150 lbs: Rarely
· 51 – 75 lbs: Rarely
· 26 – 50 lbs: Rarely
· 10 – 25 lbs: Rarely
· 1 – 9 lbs: Frequently
Environment:
· Hearing Requirements: Frequently
· Speaking Requirements: Frequently
· Working Indoors: Constantly
· Working Outdoors: Rarely
· Working in Confined Space: Rarely
· Exposure to Fumes, Chemicals, Solvents, Caustics, etc: Rarely
· Extreme Temperatures: Rarely
· Eye/Hand/Foot Coordination: Rarely
Reasoning Development:
Apply principles of logical or scientific thinking to define problems, collect data, establish facts and draw valid conclusions. Interpret an extensive variety of technical instructions in mathematical or diagrammatic form.
Deal with several abstract and concrete variables.
Mathematics: Algebra, Geometry, Shop Math, Trigonometry.
Language Development:
Reading: Read technical documents, industry standards, and guidelines with clear understanding.
Writing: Type business letters, emails, and reports with proper grammar and format.
Speaking: Speak English clearly and distinctly.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid holidays
- Paid sick time
- Paid time off
- Vision insurance
Schedule:
Application Question(s):
- What is your salary requirement?
Work Location: In person