Life Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.
The Senior AME will be the operations new production development representative and is responsible for working with multi-functional teams both locally and at various manufacturing sites to support the goals and objectives of Smith and Nephew according to strategic plans. This position is responsible for ensuring that timeline landmark commitments are achieved while meeting all Safety, Quality, and Cost requirements.
This position supports the Global Operations Advanced Manufacturing Engineering (AME) team in launching new products into production for the Smith and Nephew Biologics Franchise.
The candidate will need to demonstrate the ability to work on sophisticated programs from concept to commercialization with limited guidance from management as required.
**This position does not offer visa sponsorship**
What will you be doing?
- Operations lead for select Biologics New Product Development (NPD) programs.
- Responsible for process development, equipment specification, acquisition, and implementation.
- Works with partner groups at manufacturing sites to gain alignment and support to achieve project objectives.
- Leads design for manufacturability and process development efforts.
- Use engineering principals to understand technical problems and identify root cause and implement solutions.
- Solid understanding of key medical standards such as FDA CFR Part 820 and ISO 13485. Understand medical device requirements Installation Qualification (IQ), Operation Qualification (OQ) and Process Qualification (PQ) as it relates to production equipment validation. Responsible for protocol development and drive equipment, process, and software qualifications when appropriate.
- Mentor junior engineers.
- Effectively listens to others by asking clarifying questions to gain understanding of other points of view.
What will you need to be successful?
- Bachelor’s degree in science or engineering and at least 5 years professional work experience in new production development
- Experience in new product development, complex process development, and project management.
- Demonstrated track record for delivering new products into production.
- The ability to understand, interpret, follow, and improve Quality Systems
- Knowledge of Design Control & Process Validation is preferred.
- In-depth knowledge of Operations work / documentation is preferred.
- Experience in biological processing is preferred.
- Selects techniques to tackle sophisticated problems and make sound design/process recommendations.
- Excellent project management, communication, and leadership skills.
- Excellent analytical skills.
- Excellent interpersonal communication skills
- Strong verbal and written communication and presentation skill
- Able to lift 25 pounds, Able to view items through microscope, Extended periods of time doing computer-based work.
- Travel up to 10%.
You. Unlimited!
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more aboutEmployee Inclusion Groupson our website (https://www.smith-nephew.com/).
Other reasons why you will love it here!
- Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
- Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day
- Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
- Flexibility: Hybrid Work Model (For most professional roles)
- Training: Hands-On, Team-Customized, Mentorship
- Extra Perks: Discounts on fitness clubs, travel and more
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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