Location: Añasco, PR

Summary:
The Manufacturing Engineer II, Life Cycle Management (LCM) will work within the Integra Lifesciences CSS Engineering organization to support the design changes impacting operations, manufacturing, launch readiness and production stability requirements of existing products.

Responsibilities:

• Provide technical expertise and project leadership in the areas of medical device life cycle management, supplier change management, COGs, process development, validation and production stability.
• Perform each essential duty satisfactorily.
• Participate on cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and manufacturing to maintain and improve surgical products.
• Responsible for reviewing and updating applicable product specifications and drawings for legacy products.
• Responsible for identifying acceptance criteria for product specifications.
• Develop project plans for qualifications and ensure team resources identified, team members help accountable to deliverables, and milestones met.
• Provide engineering knowledge and resolve design, manufacturing, and quality-related problems impacting existing products.
• Develop and issue change control documentation to address changes in components and/or raw materials requested by the suppliers following applicable procedures.
• Ability to adjust priorities when with shifting business needs.Support manufacturing process improvements for CSS products in both internal manufacturing facilities and in partnership with external suppliers.
• Provide project leadership to improve existing products and associated manufacturing processes.
• Support the selection and validation of replacement materials, such as polymers, metals, and adhesives, for CSS applications.
• Support corrective actions and the implementation of all corrective actions to ensure improvements are attained.

Qualifications:

• Bachelor of Science in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
• Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment.
• Lean/Six Sigma Green or Black Belt Certification is a plus.
• Experience in validations such as: manufacturing equipment, manufacturing processes, stability or aging, required. 

Skills and Knowledge:

• Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
• Knowledge in Organizational Excellence and Lean/Six Sigma.
• Strong Project Management skills.
• Ability to lead teams through complex projects and provide departmental technical leadership.
• Must have excellent communication skills and a strong track record of working cross-functionally.
• Must have demonstrated ability to think strategically.
• Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
• Teamwork oriented and self-starter.

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers health benefits that include vision, dental, and pharmacy. Additional benefits offered to eligible employees include a 401K retirement plan with employer matching, a referral bonus program, and an EAP (Employee Assistance Program). SPECTRAFORCE provides unpaid leave as well as paid sick leave and vacation when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at benefits_pr@spectraforce.com if you require reasonable accommodation. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $30.10/hr.