Associate R&D Manager-Approvals EngineeringResponsible for primary hiring, on-time performance appraisals, coaching/counseling, employee development and necessary communications regarding performance issues.
ESSENTIAL FUNCTIONS:
1. Plans, organizes, staffs, directs and controls the engineering function within appropriate guidelines, policies and regulations.
2. Establishes and guides goals and accomplishments of the team/department.
3. Responsible for primary hiring, on-time performance appraisals, coaching/counseling, employee development and necessary communications to regarding performance issues.
4. Possesses and applies a broad knowledge of principles, practices, and procedures to ensure conformance to US and international electrical, mechanical, and software standards, regulations, and initiatives.
5. Provides direction and support to cross functional team members with respect to compliance testing, design, and sustainment activities in relation to approvals engineering activities.
6. Develops, maintains and revises the approvals engineering schedules to insure project timelines are met.
7. As necessary, participates in audits by regulatory compliance agencies in order to provide expertise and input for technical issues, actions or decisions.
8. Develops status reports and other related communications.
9. Operates within budget and organizations guidelines and philosophy by implementing cost reduction programs through value analysis.
10. Plans and coordinates with other engineering areas to ensure the timely and efficient product production.
11. Accountable for all record-keeping as appropriate and in accordance with Stryker specifications.
12. Works as a key member of an interdisciplinary business team to drive business performance.
13. Drive and develop increased team engagement over time.
14. Understand organizational need to remove under performers and develop the next generation of leaders.
15. Talent Exportation.
16. Responsible for establishing the budget and strategic directions achieving goals.
17. Expected to handle complex or difficult situations as appropriate.
18. Travel up to 25% to support business needs.
QUALIFICATIONS:
• Undergraduate degree in Engineering or equivalent, Bachelors of Science in Electrical Engineering preferred.
• MS/MBA desired.
• Three to five (3-5) years experience as a technical manager in approvals engineering, research and development, quality assurance, regulatory affairs, or associated field.
• At least two (2) years experience working in the medical device industry or similarly regulated environment.
• Basic skills - Time management, project management, reports and budget, stress management, conflict management, re-engineering, customer service, ISO, Windows, PC literate.
• ERP, statistics, manufacturing process, metrology, auditing, mechanical support, blue print reading, financial systems
• Functional skills - Product knowledge, material flow and paperwork.
• FDA and ISO design and process control systems
• Stryker specific skills - Financial systems, HR system, manufacturing systems, organizational structure and design engineering interface.
• Ability to make decisions impacting team members regarding training, coaching/counseling and appropriate follow-up.
• Ability to make decisions in regards to compliance issues, product reliability and analysis of testing methodologies.
Qualifications/Work Experience
•3-5 years experience as a technical manager in approvals engineering, research and development, quality assurance, regulatory affairs, or associated field.
•At least(2)years experience in the medical device industry or similarly regulated environment.
•ERP, statistics, manufacturing process, metrology, auditing, mechanical support, blue print reading, financial systems
Education and/or Special Training
• Undergraduate degree in Engineering or equivalent, Bachelors of Science in Electrical Engineering preferred.
• MS/MBA desired
Percent Travel Required
25
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