Senior Design Transfer Manufacturing Engineer - Orthofix : Job Details

Why Orthofix?

Guided by our organizational values - Take Ownership | Innovate Boldly | Win Together - we collaborate closely with world-class surgeons and other partners to improve people's quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech.

Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people's lives? Look no further.

How you'll make a difference?

This position is responsible for designing, maintaining, approving & optimizing manufacturing processes required to assure on-time and cost effective delivery of medical device products. Utilizes state of the art technology and automation whenever possible to optimize efficiency of processes. Provides shop floor support to assure on-time delivery of new and existing products. Leads Continuous Improvement activities and represents manufacturing engineering as a project core team member responsible for Design Transfer, conducting and supporting process validations.

What will your Duties and Responsibilities be?

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

* Develop, document, evaluate, monitor and improve manufacturing processes through process analysis, risk assessments and process Design of Experiments.

* Work with the Design Team to define the manufacturing process, manufacturability and effective design transfer of new products to commercialization.

* Prepare and present return on investment proposals (ROI) for management review, regarding anticipated capital equipment purchases, process improvements, quality improvements.

* Responsible for selection, installation, qualification (IQ/PQ/OQ) of tooling and/or capital equipment utilized in product manufacture.

* Define tooling and equipment,including the development of custom manufacturing equipment, from user requirements through design, delivery and qualification.

* Create project schedules and provide budgetary input for cost reduction and new product projects. Documents project activities.

* Participate in the selection and qualification of new suppliers. Works closely with suppliers, purchasing and development to ensure design requirements are adequately defined and met.

* Ensure new product manufacturability by conducting research, feasibility testing, and process validation.

* Conduct and document verification/validation/engineering testing.

* Conduct time studies to determine accurate labor standards for products supported.

* Set up workflow routers and bill of materials in ORACLE/AGILE database.

* Generate and implement Engineering Change Orders.

* Support production by developing shop aides/fixtures, manufacturing procedures, drawings & specification interpretation.

* Provide progress reports to management as required.

* Monitor and provide periodic reports on component product quality and take appropriate action to reduce costs due to defects.

* Lead cross functional teams for the purpose of post market and continuous improvement activities.

* Regular attendance required.

What skills and experience you'll need?

* Bachelors Degree, preferably in an Engineering discipline.

* Ability to measure the risk levels of a process and develop robust controls that lower risk levels

* Ability to test and define process input variables to result in high process capabilities by means of Design of Experiments and multivariate analysis.

* Solidworks CAD experience

* Working knowledge of Microsoft applications including MS Project.

* Minimum 5 years prior Manufacturing Engineering experience in a medical device or pharmaceutical environment.

* Strong problem solving skills.

* Effective communication skills.

* Self motivated.

* Ability to work effectively under pressure to meet deadlines.

* Solid organizational skills-able to handle multiple tasks simultaneously.

What Skills would be helpful?

* Class 3 spinal implant design and manufacturing.

* Pro-E CAD software experience.

* CNC swiss programming/machining

* Machine tooling design

* Familiarity with ORACLE and Agile Manufacturing applications.

* Experience in a Lean Manufacturing environment.

* Six Sigma Greenbelt Certification

What will the Physical Demands and Work Conditions be like?

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

* Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 40 lbs.

* Eyesight and hearing must be correctable to standard level.

* Travel to sites to call on vendors, customers up to 50% during the year.

* Attend surgery or observations as needed.

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.

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, religious creed (including religious dress and grooming practices), color, caste, 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 (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, 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.