Senior Engineer - Medical Device
|Location:||Salt Lake City, UT|
|Employment Type:||Full Time|
|Employer:||Prince, Perelson & Associates|
|Description:||1. Initiates new or revised documentation and tracks through appropriate approval cycles and implementation|
2. Maintains a professional working relationship with internal & external customer and support staff
3. Participates and leads cross-functional teams.
4. Provides technical support on components, material methods, systems and equipment.
5. Develops physical and functional test requirements to assure specifications & regulations are met.
6. Writes and approves protocols, reports and data.
7. Manages testing outlined in protocols and test methods
8. Manages/develops validation studies on equipment & processes
9. Conducts complaints investigations
10. Executes design controls
11. Participate in collecting/developing and analyzing design inputs
12. Understands and follows company procedures and regulatory requirements.
13. Participates in and provides input to training on department & division procedures, and policies.
14. Manages project planning, budgeting, scheduling and tracking.
15. Plans and coordinates engineering test builds.
16. Analyzes problems in design, process and test development. Recommend/implement solutions.
17. Prepares and presents oral and written project updates and technical discussions.
18. Develops and implements procedures/policy.
|Duties:||KNOWLEDGE AND SKILLS:|
1. Ability to make and present engineering decisions
2. Strong interpersonal skills
3. Ability to systematically manage multiple projects from initiation through closing phases.
a) Determine and communicate project deliverables
b) Develop a work breakdown structure and estimates
c) Develop a viable schedule, management plans, and schedule
d) Execute and control the project through closure
4. Specific specialized engineering skills such as:
a) Create & critique engineering cost analysis
b) Basic tooling design and drafting knowledge
c) Analyze and optimize existing process and ability to create new processes
d) Create, analyze and optimize manufacturing and quality systems
e) Basic product, design & prototyping
f) Material Science
g) Bioengineering principles
5. Ability to train, create and critique training
6. Ability to apply Comparative statistics
7. Software application skills
8. Problem solving ability
9. Ability to create, review and coordinate test protocols and reports
10. Ability to generate engineering proposals.
11. Oral and written presentation skills
12. Ability to lead cross functional teams
14. Ability to manage development programs at suppliers
13. Comprehensive understanding of regulatory environment
14. Demonstrated ability to create and execute project plans
15. Demonstrated Supervisory skills
16. Ability to create and control a budget
17. Advanced multi-project management skills
18. Diverse technical background
|Qualifications:||This position requires:|
• a Bachelor degree in science or engineering with 6 years of engineering experience within the medical device or equivalent regulated industry OR
• Master’s degree with 5 years of engineering experience within the medical device or equivalent regulated industry
The above experience must include 3 years’ proven and effective project management skills.
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