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Form of workLife Unlimited. At Smith+Nephew, we design and manufacture technology that takes the limits off living.
The Project Engineer 2 will develop and implement new (or modify existing) manufacturing processes and technologies, both at the Fort Worth site and at other locations globally to deliver validated manufacturing process from concept to hand-over.
This position will ensure quality and compliance measures are met and accurate documentation is completed to align with quality, compliance, and operating procedures. You will need to complete and understand documentation needed to follow our policies, Quality Manual, and procedures including but not limited to:
Applicable standards as defined in the Quality manual (including but not limited to):
Applicable regulations as defined in the Quality Manual (including but not limited to):
What will you be doing?
What will you need to be successful?
You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
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.
Stay connected and receive alerts for jobs like this by joining our talent community.
We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.
Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.
Explore our new website and learn more about our mission, our team, and the opportunities we offer.
The Project Engineer 2 will develop and implement new (or modify existing) manufacturing processes and technologies, both at the Fort Worth site and at other locations globally to deliver validated manufacturing process from concept to hand-over.
This position will ensure quality and compliance measures are met and accurate documentation is completed to align with quality, compliance, and operating procedures. You will need to complete and understand documentation needed to follow our policies, Quality Manual, and procedures including but not limited to:
Applicable standards as defined in the Quality manual (including but not limited to):
- ISO 9001
- ISO 14001
- ISO 13485
Applicable regulations as defined in the Quality Manual (including but not limited to):
- EU Medical Device Directive / Regulation
- Regulations issues by the 5 MDSAP Jurisdictions
- UK Human Medicines & Medical Device Regulations
- cGMP, cGDP (including 2013/C 343/01), cGLP as application for each role.
What will you be doing?
- Work with external suppliers, contractors, and S+N sites to ensure project achievements are met.
- Ensure all change Control activity is handled efficiently.
- Manager project finances in line with required processes.
- Generate original validation protocols, hand-on execution of the works and reporting thereof with minimal direction.
- Perform/lead critical engineering activities including FAT, installation, commissioning, SAT, IQ, OQ, and PQ.
- Training of manufacturing personnel and hand-over into normal manufacturing.
- Start-up support, ensuring no service problems are created.
- Manage key suppliers.
- Identify and resolve sophisticated technical and operational challenges related to products and manufacturing processes.
- Demonstrate strong influencing skills at all levels of the organization and ensure regular project updates are communicated to the appropriate teams and leaders.
- Establish regular communication channels for partners, multiple sites, and project teams.
What will you need to be successful?
- BSc in Engineering, Science, or related field
- Technically competent in engineering principles and understand a wide range of manufacturing technologies and S+N products.
- Engineering apprenticeship rout plus Project Engineering experience in a highly regulated industry.
- MSc preferred.
- IOSH Managing Safely and/or NEBOSH General Certificate preferred.
- Lean Sigma Greet Belt preferred.
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- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).
- Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
- Work/Life Balance: Flexible Personal/Vacation Time Off, 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.
Stay connected and receive alerts for jobs like this by joining our talent community.
We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.
Check our Glassdoor page for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.
Explore our new website and learn more about our mission, our team, and the opportunities we offer.
