We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning! Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!
How you’ll make a difference:
This position is responsible to develop and improve new as well as existing manufacturing methods, equipment, and processes utilizing Innovative approaches to produce a high quality product at optimal cost. Projects assigned are typically of small to moderate size and can pose significant risk to product and/or processes if not designed and implemented correctly. The colleague should be able to complete project assignments in a timely manner with minimal supervision.
Your key responsibilities:
- Provide engineering support to manufacturing operation to meet manufacturing objectives and address product related issues arising from the production floor on a routine basis.
- Perform timely technical investigations and provide practical manufacturing solutions utilizing problem solving skills and techniques to identify root causes, corrective and preventative actions, develop and implement mitigation and resolution plans and activities.
- Define and generate all required documentation in support of manufacturing products and processes ensuring compliance with FDA GMPs, applicable regulatory standards, and internal protocols/procedures. These include but are not limited to: IQ/OQ/PQ/PV validation protocols and reports, FMEAs, packaging design and validation, equipment and tooling design, and manufacturing procedures.
- Continually improve manufacturing methods, systems, and processes to optimize product performance and reduce manufacturing costs. Identify and evaluate opportunities for improvement and make specific recommendations for adoption. Develop plans to evaluate process repeatability and stability through equipment qualification and process validation applying six sigma methodologies as appropriate.
- Lead and coordinate activities of cross functional teams which may include personnel from Engineering, Manufacturing, Research & Development, Marketing, QA, and Clinical & Regulatory Affairs.
- Support new product development or existing product line extensions/modifications (R&D Design Transfers or Plant Transfers) by ensuring manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields.
- Must be able to adhere to SeaSpine’s Health and Safety and Quality guidelines as they relate to the departments controlled environments.
Who you are:
- B.S. in Engineering
- Minimum 3-5 years in medical device manufacturing or manufacturing in highly regulated environment is required
- Excellent oral and written communication skills to effectively convey requirements, resolve conflicts, and achieve objectives
- Solid interpersonal skills and ability to work in a team environment.
- Strong project management, time management, and analytical/problem solving skills as demonstrated through work experience.
Preferred Qualifications:
- B.S. in Manufacturing or Mechanical Engineering preferred
- Six Sigma or Lean Manufacturing is desired
- Experience in biomaterials is desirable
- Experience with Computer Aided Drafting programs (Solidworks, ProE, AutoCAD)
- Proficient in statistical analysis
The anticipated salary for this position is $105,000 to $116,000 per year, plus bonus, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, color, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws.
This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.