Senior Quality Engineer
We currently have availability for a Principal/Senior Quality Engineer to join our growing team. Blockade Medical, a Balt Company, is currently seeking an experienced Principal/Senior Quality Engineer with a minimum 5-7 year’s medical device experience in a quality control environment which includes performing quality inspections, assisting in developing new inspection and test methods, and working with the Operations and R&D teams on quality issues and initiating document changes. The position will also be an integral part of the project team for launching new products.
- Understanding inspection techniques and documentation including mechanical drawings
- Working in controlled environments (clean rooms)
- Knowledge of Quality Systems for medical device manufacturing including requirements for inspection and testing
- Plan, document (protocol and reporting) product/process validations
- Performing audits of the Quality Systems, both internal and vendors. Internal audit responsibilities includes the full-cycle internal audit planning, conducting, as well as developing, completing and reporting of corrective action plans. Vendor audits include participation in supplier qualification activities and audits.
- Initiates and/or verifies corrective and preventative actions resulting from NCMR’s, audit findings and customer complaints
- Develop and complete qualifications for new or changed materials and process
- Identify/evaluate quality inspection/test equipment requirements
- Lead Quality Circles for process improvement/problem solving
Blockade Medical, a Balt Company, is growing and we are looking to expand our R&D Engineering team with an experienced, Level II, III or Senior R&D Engineer. A BS degree in Mechanical Engineering, Biomedical Engineering or related discipline is required with a minimum two (2) years’ experience specifically with an endovascular or medical device related background. This role will be supporting the development and manufacture of medical devices by working with the Manufacturing and Quality departments to design, develop, validate and qualify new products.
Responsibilities will include
- Development of new product concepts and products
- Completing projects following design control procedures
- Developing test methods and test fixtures
- Design, develop, refine and improve current products
- Identify processes and improvements and materials to be used in products
- Prepare product documentation
- Write and supervise test protocols, test data and test reports
- Gather input from clinical, marketing, literature, and other internal sources
- Identify problems and recommend solutions
- Assist Project Manager in scheduling and coordinating project related activities, including team meetings and design reviews
- Execute material procurement, shipping requests and documentation
Senior International Regulatory Affairs Specialist
Blockade Medical, a Balt Company, currently has a position available for a Senior International Quality Affairs Specialist to join our growing team. As a key-contributor to obtaining various worldwide approvals to commercially distribute medical products, we are seeking an experienced Regulatory Affairs Specialist with a minimum 5 year’s medical device experience, who is proficient in determining applicable registration requirements and producing submission documentation, product registrations, etc.
- Proficiency in preparing required documentation and testing for global regulatory submissions and registrations
- Determine applicable registration requirements for medical devices in all countries in which products are registered
- Interpret and/or evaluate proposed registration requirements and advise of impact of such regulations on the Company
- Review and approve labeling and promotional materials to ensure compliance with international requirements
- Work directly with consultants to manage all submissions for a particular country or countries
- Handle customs import/export requests, customer service needs, and other requests from internal customers
- Support the International Regulatory Department with regards to regulatory strategies, submissions and discussions/negotiations with regulatory authorities
- Manage communications and submission processes of global registrations including general correspondence, reports and amendments
- Proficiency in maintaining global regulatory requirements
Senior Pilot Manufacturing Engineer
This fast paced position will be responsible for the transfer of neurovascular products from our international facility to our United States manufacturing facility. The transfer will include a mixture of process development and validation activities by evaluating our current processes at our international facility, streamlining these processes, and developing a test plan for each of these changes as necessary. Further, each product will require additional validation activities for a US approval. This role will be responsible for accomplishing those activities as well.
- Worked in a Process Development group and is familiar with V&V testing activities for CE/FDA approval.
- A demonstrated ability to plan and run multiple projects simultaneously.
- Ability in starting up a pilot manufacturing line.
- Four-year degree required in Engineering with 5-10 years as an Engineer in medical devices.
- Deep process validation experience and Class III, IIb Implantable Medical Device Experience
- Design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.
- Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
- Strong analytical, problem solving and project management skills.
- Ability to travel approximately 15%, internationally.
- SolidWorks proficiency is a must.
- Microsoft Project, Microsoft Visio, and Microsoft Access proficiency are highly desired.
- Statgraphics or a statistical analysis skill set is required
- Neurovascular experience is a plus
The Senior R&D Engineer role will support the design and development medical devices. Catheter manufacturing or design experience required. The candidate will gather input from Clinical, Marketing and literature to develop new products and improve existing product lines. The candidate will be responsible for managing projects following design control procedure, develop test methods, test fixtures and manufacturing processes. The candidate will prepare design history file documentation, generate test protocol and reports. The candidate will assist the project manager in the scheduling and coordination of project related activities including team meetings and design reviews.
- BS degree in Mechanical Engineering, Biomedical Engineering or related discipline.
- Must have a minimum of two (2) years of experience in the medical device field with preference to endovascular devices.
- Experience with industry related software MiniTab, Statgraphic and Solidworks.
- Strong planning and organizational skills. Able to effectively multitask.
- Strong written and verbal communication skills.