About the Role:
Alio is seeking an experienced Manufacturing Engineer to support production to ensure internal KPIs are met and collaborate with external customers and internal teams to address quality issues related to new products. Alio is a global medical device provider, revolutionizing the medical industry with a unique product emerging onto the market.
This position plays a major role in the company's manufacturing processes. Responsible for identifying and documenting the specification requirements of manufacturing equipment to meet manufacturing needs.
- Develop strategic processing goals and objectives and integrate processes into value streams.
- Product design/development (design control) from concept through the 510k and PMA approval process.
- Strong background in the engineering of electro-mechanical and disposable medical devices.
- Ability to model and analyze mechanical systems and assemblies.
- Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), and FMEA.
- Knowledge and experience in Good Documentation Practices (GDP)
- Hands-on experience in planning and executing engineering tests including preparation of test protocols and reports
- Knowledge of FDA QSR and requirements for developing and qualifying a medical device
- Strong problem-solving, risk assessment, and risk management skills.
- BS in Mechanical Engineering and previous experience in a medical device, or similar industry, with 2 - 6 years of current experience with engineering processes and procedures.
Familiarity with the following standards:
- 21CFR820 Quality System Regulation
- ISO 13485 - Medical Device
- ISO 14971 Risk Management
- EU Medical Device requirements
- Medical devises Directive 93/42/EEC
- Medical Electrical Equipment
- EN 60601
- Interface with Engineering Technicians and production personnel to streamline and optimize manufacturing processes within a LEAN manufacturing environment.
- Support project teams in the development of medical devices. The qualified candidate will support technical teams to ensure successful device development of electro-mechanical medical devices.
- The Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, and regulatory submissions of these devices.
- Work cross-functionally with individuals and within project teams.
- Create and assess product requirements to determine technical coverage and proper integration of different subsystems.
- Must be capable of working on multiple projects in a deadline-driven environment.