Robling Medical, Inc. is currently searching for the following positions. With a great culture and strong leadership, we are making a positive difference in patients’ lives everyday.
Open Positions
General Summary – Responsible for serving as a member of a Cross Function Customer Focus team and assisting the QA Manager in the maintenance of the Quality Management System. Responsible for assuring compliance with Quality System Procedures through the support of QA personnel.
Primary Duties and Responsibilities
- Assist in the development and review of Purchasing Specifications and receiving inspection criteria as new products are brought on line.
- Responsible for gaining a comprehensive understanding of the manufacturing process prior to transfer to manufacturing and for assisting in the transfer to manufacturing through training of QA inspection and manufacturing personnel.
- Develop and maintain verification and inspection procedures, methods, and sampling plans to assure customer requirements and product specifications are met.
- Lead in the development and maintenance of Limit Samples and other inspection aids
- Lead all Risk Assessment activities
- Lead QA Specialists in the Nonconforming Materials Control Process by assuring non-conformances are investigated, controlled, documented, resolved and closed in a proper and timely manner
- Perform investigations and document findings related to Corrective Action and Preventive Actions that are initiated. Performs follow-up verifications after CAPA Plans are implemented
- Evaluate, summarize and report on quality data and Key Performance Indicators to assure problems are being adequately addressed and there are no indications of trends or system breakdowns.
- Provide support to other Managers and Engineers related to Cost Savings and continuous improvement Initiatives
- Provide interface and communications with customer and suppliers on all quality concerns.
- Develop and maintain training modules and training effectiveness assessments related to quality procedures and practices
- Review and approve Validation Protocols and Reports
- Assist in the execution of Validation activities as required.
- Interfaces with Suppliers regarding incoming quality issues
- Performs Supplier Audits
- Conducts Internal Audits
- Other duties as assigned
Required Qualifications
- 4 year BS degree or equivalent applicable experience
- Proficient in the use of Quality Management Tools
- Proficient in MicroSoft Office Suite
- Strong writing skills
- Strong verbal communications skills
- Proficient in interpretation of regulatory requirements and standards
- Strong Analytical skills – Cause and Effect Analysis
Preferred Qualifications
- ISO 9001 or ISO 13485 Certified Auditor
- Experience in the performance of Supplier Audits / Evaluation
- Experience in the appropriate selection of Statistical Tools
Environment & Working Conditions
- Lifting – 30 lbs
- Ability to work in a cleanroom environment
- Standing for long periods of time
- Bending
- Sitting for long periods of time
- Visual – Constant Visual attention
General Summary
The Program Manager is responsible for leading cross functional teams for all customer programs in the routine monitoring and communication of production status and for overseeing and driving new product development in the design, development & validation of robust products, processes, assembly tools & methods, manufacturing processes, etc. This position: 1) requires technical expertise in creating & maintaining project plans, tracking project performance, developing & maintaining project & engineering reports, & communicating routinely on all aspects of projects to all stakeholders; 2) assists the Engineering team with the development of cost-effective & efficient processes; and 3) leads cross functional teams in the transfer of new products to the Robling Medical manufacturing environment on time.
Primary Duties and Responsibilities
- Technical and Hands-on Leadership for the Following:
- Customer Relationship & Project Team Leadership & Oversight (Customer Focus Team Leader)
- Project File Setup & Maintenance
- Project Scope & Cost Oversight/Control & Reporting
- Cross Functional Team Leadership – Internal & External Resource Coordination for Engineering Projects (Including Scheduling & Tracking of ENG Builds)
- MVP Initiation & Management thru V&V Phase
- New Vendor Selection, Relationship Development, & Supply Chain Development Support
- Material Specifications, Bills of Material, Assembly & Packaging Instructions Initiation
- Product DFMA Assistance & Support (Including Sterile Pkg & Shipping Configuration Design)
- Risk Analysis Support
- [Assembly] Process Development Support
- Test Method Development Support
- CAD/Drafting & Tooling/Fixturing Support
- MFG Line Design & Setup Support
- Validation Protocol Development & Report Writing Support
- XFER to MFG Support – Finalizing Validation Docs, Line Setup & Training
- Department Procedure Development & Maintenance Support
- Assistance in Ensuring Compliance/Adherence to Internal, Contract, FDA, & ISO Requirements
- Assistance in Quoting New Business Opportunities
Required Qualifications
- 4-year degree in an Engineering field (Biomedical, Mechanical, Industrial or Electrical) with at least 5 years of experience in the field
- Strong project management skills
- Demonstrated ability to lead & manage a team
- Excellent interpersonal skills & written communication
- Strong analytical skills & attention to detail
- Highly motivated self-starter with ability to drive for results
- Demonstrated ability to effectively organize, prioritize & accomplish multiple tasks; makes decisions & solves problems independently
- Background in medical device development & manufacturing
- Experience working with medical device compliance to FDA & international standards
- Experience in a fast-paced environment where ‘speed to market” is identified as a key performance indicator
- Strong computer skills (MS Word, Excel, PowerPoint, Outlook, Project Management Tools, CAD, Statistical Software, Graphic Design Tools)
Preferred Qualifications
- Experience in an ISO 9001 or ISO 13485 manufacturing environment
- Medical Device or Pharmaceutical development or manufacturing experience
- Experience with device sterile packaging & terminal sterilization processes such as EtO, Gamma, etc.
- Technical skills in manufacturing processes and methods including flow, layout, assembly and production equipment
- Cross-discipline engineering experience
- Experience in developing & maintaining pFMEAs
- Experience in troubleshooting and repairing equipment
- Experience with heat sealing, vacuum forming, RF welding, high speed packaging lines, adhesive dispensing systems, cutting/punching/skiving/forming thermoplastics, inspection and test equipment (leak testing, scales, force gauges, etc.)
- Lean Six Sigma Green Belt Certification
- Experience with MiniTab
- Experience with SolidWorks
- Experience with electro-mechanical devices & equipment (design, fabrication/assembly, installation, qualification, operation)
Environment & Working Conditions
This position is generally performed indoors in a plant or office environment and requires specific physical requirements that must be met, including:
- Some heavy lifting and considerable moving of equipment (lifting up to 50 pounds)
- Standing for long periods of time
- Sitting for long periods of time
- Bending
- Ability to reach with hands and arms
- Visual – Constant visual attention (i.e., color vision, depth perception, ability to adjust focus).
General Summary
The Engineering Technical Writer/Project Administrator is responsible for the research, organization and compilation of technical documentation for the company’s engineering projects. This person: 1) maintains proper methodology to ensure consistency, efficiency, accuracy, and compliance with company and ISO standards; 2) assists the Project Engineers with the research and collection of technical documentation required for the preparation of company manufacturing documentation, 3) leads the initiation & creation and assists with the maintenance of the company engineering and manufacturing documentation, which may include material specifications, bills of material, work instructions, inspection requirements, controlled artwork files, drawings and other documentation; and 4) assists Engineering Project Managers in keeping engineering project files and schedules current and accurate.
Primary Duties and Responsibilities
- Supports multiple projects by ensuring documentation is accurate, complete and current
- Conducts appropriate research related to documentation and projects
- Ensures all documentation is compliant with company requirements and standards
- Communicates with customers, vendors, employees, etc. regarding established technical specifications and to determine subject material to be developed
- Reviews published documentation and recommends revisions or changes in scope, format, context, etc. as needed
- Studies drawings, specifications, mockups and product samples to integrate and delineate technology, operating procedures and production sequence
- Interviews appropriate employees and reads journals and other material to become familiar with product technologies and production methods
- Observes production, developmental and experimental activities to understand and determine operation procedure and detail
- Organizes and formats all documentation, which may include drawings, specifications, data sheets, charts, graphs, etc.
- Ensures all documentation and project files are accurate, complete and up to date and distributes as required
- Participates in special projects as required
Required Qualifications
- Minimum of 2 years’ experience in a technical writing field or technical engineering support role
- Advanced computer skills, especially Microsoft Office products (Word, Excel, PowerPoint, Project), Corel Draw, Acrobat Pro, Paint Shop, etc. Must be comfortable formatting drawings, technical data, etc.
- Superior written and verbal communication skills
- Flexibility and the ability to interact with all levels of employees as well as customers and vendors
- Extremely thorough and accurate and a penchant for detail
- Demonstrated technical aptitude
- Exceptional organizational skills
- Highly motivated and able to grasp complex software and learn quickly
- Ability to deliver high quality documentation
- Minimum 2-5 years’ experience in an ISO compliant manufacturing environment
- A sample of prior work may be required to be submitted at interview
Preferred Qualifications
- Mechanical assembly aptitude demonstrated through process details experience
- Associates degree in Technical Writing, an Engineering field of study or similar technical discipline
- Medical device or pharmaceutical experience
Environment & Working Conditions
- Sitting for long periods of time
- Visual – constant visual attention
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