Sr. Engineer II - Packaging

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact. Arthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insurance Voluntary Life Insurance Flexible Spending Account (FSA) Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan Annual Bonus Wellness Incentive Program Free, Onsite Medical Clinics Free Lunch Tuition Reimbursement Program Trip of a Lifetime Paid Parental Leave Paid Time Off Volunteer PTO Employee Assistance Provider (EAP) Please note, most benefits are for regular, full time employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law. Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Sr. Engineer II - Packaging. This individual will provide packaging engineering support for design engineering projects, as well as support and assist packaging engineering development goals in support of overall business goals. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™. Essential Duties and Responsibilities : Coordinate Packaging Development activities for new MPI’s and product improvement projects. This may include but is not limited to the following : Create and maintain packaging engineering specifications utilizing CAD, 3D modeling software, or other software tools. Create and maintain packaging designs for sterile and non-sterile products. Select appropriate packaging materials based on product and sterilization requirements. Create and maintain Packaging Instruction documents for the final manufacturing packaging assembly of finished devices. Communicate (not execute) packaging process validation activities with manufacturing or designated design team member for Arthrex products. Coordinate and execute packaging design validation activities post packaging process approval. Oversee any required package testing to assure viability of packaging / product construct for sterile and non-sterile barrier protection. Generating protocols, test reports, and engineering adoptions and maintenance of test documentation per approved documentation system per quality standards. Ensure essential packaging development activities are completed prior to packaging design transfer activities. Coordinate Instrument Case development activities for new MPI’s and product improvement projects. This may include but is not limited to the following : Coordinate and Create Instrument Case Layouts with Design Team and Contract Suppliers. Create and maintain Instrument Case Specifications. Oversee Design Verification and Validation activities for Instrument Cases. Lead Instrument Case project when Instrument Case is a standalone MPI. Provide support for packaging engineering related CAPA’s. Provide supporting packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits. Create Bill of Materials and generate Engineering Change Orders (ECO) in support of new products and various revisions or maintenance. Communicate effectively with Design Team members and Contract Suppliers using project management tools, written, and verbal communication. Support product design changes to develop and improve existing products that affect existing packaging. Oversee any required package testing to assure viability of packaging / product construct and sterile barrier protection. This includes Provide supporting packaging documentation to Regulatory and Quality for 510(k) and ERC submissions and audits. Create Bill of Materials and generate Engineering Change Orders (ECO) in support of new products and various revisions or maintenance. Communicate effectively with Design Teams and Contract Suppliers using project management tools, written, and verbal communication. Education / Experience : Bachelor's degree in Engineering required; preferably in Packaging Engineering Minimum of 8 years of experience in Packaging Design and Development or Manufacturing required Medical device packaging or manufacturing environment experience preferred Knowledge : Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices. Discretion / Latitude : Work is performed under minimal direction.Participates in determining objectives of assignment. Plans, schedules, and arranges own activities in accomplishing objectives. Work is reviewed upon completion for adequacy in meeting objectives. Skills : Advanced capabilities in designing complex packaging designs and packaging instructions using a CAD program (AutoCAD or Solidworks) required. Proficient at leading DHF projects for Packaging only and Instrument Case projects. Advanced knowledge of packaging validation process as required by quality and regulatory standards. Advanced capabilities of researching new packaging materials and suppliers for manufacturing process improvements and / or cost reductions. Advanced capabilities in leading Global Packaging Projects for design and / or packaging process improvements. Advanced ability of writing and approving technical documentation internally. Advanced capability of reviewing and approving technical documentation from external packaging subcontractors. Able to coach, mentor, and supervise technicians and / or junior packaging engineers. Proficient at creating packaging procedures and providing training on procedures. Advanced knowledge of design and manufacturing processes and ability to incorporate improvements into designs Proficient at specifying and communicating design, process, or other packaging related improvements with manufacturing and contract packagers. Proficient at supporting and participating in internal and external audits in support of regulatory compliance. Incidental Duties : The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management. Mathematical Skills : Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. Language and Communication Skills : Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures. Physical Demands : The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to talk or hear.The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and / or move up to 10 pounds. Vision Requirements : Visual acuity necessary to do the job safely and effectively. Work Environment : The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The area that this job is performed in is a general office or open cubicle / workstation environment.The noise level in the work environment is usually moderate. Arthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insurance Voluntary Life Insurance Flexible Spending Account (FSA) Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) Matching 401(k) Retirement Plan Annual Bonus Wellness Incentive Program Free Onsite Medical Clinics Free Onsite Lunch Tuition Reimbursement Program Trip of a Lifetime Paid Parental Leave Paid Time Off Volunteer PTO Employee Assistance Provider (EAP) All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.