What are the responsibilities and job description for the Mechanical Validation Engineer - Medical Devices position at Planet Pharma?
***PLEASE NOTE: We are not accepting 3rd party and/or Agency candidates at this time***
Job ID: 617486
Our client, a leading Medical Device company, is seeking an experienced Mechanical/Biomedical Engineer with validation skills. This is a fully onsite role and there are no work-from-home exceptions. Please only apply if you either live in the Boston area or planning to relocate on your own. See below for other tasks/duties!
Top 3 technical skills that are required for the role:
- Validation Experience IQ/OQ/PQ
- Test Method Validation
- Problem Solving/Process Improvements
Responsibilities:
- Provides technical and sustaining engineering support in a manufacturing area.
- Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies manufacturing techniques as well as production yields for existing products.
- Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
- Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
- Interacts with product design and development personnel to ensure that processes and designs are compatible.
- May develop and conduct statistical analysis or recommend additions to document work.
- Leads the innovation development and/or optimization of new manufacturing concepts processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work material selection process and equipment selection tooling fixture and equipment installation and assessment of inputs outputs and alignment to requirements.
- Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
- Ensures processes and procedures are in compliance with regulations.
Requirements:
Bachelor's Degree (within an Engineering realm) 2 years of applicable experience
Nice To Have:
- Medical device design, development & manufacturing, experience of products with electrical functionality an advantage
- Examples of critical thinking and proven project execution
- Leading a cross functional teams and leveraging solid PM skills e.g. project planning, communication, risk management, etc.
- Work collaboratively and with respect & humility with a cross functional team to drive project execution for medical devices, prioritizing safety, quality service, on-time execution.
- Lead team to define goals, provide solutions and align on path forward, drive/track/communicate progress, adapt as needed with team.
- Read and understand quality management system documents that provide details of business processes to be used and comply with those procedures.
- Use scientific problem solving methodologies e.g. DMAIC, process map, 5 whys, Is/Is not, etc. Drive solid decision making.
- Attention to detail, accuracy, to ensure own work meets required standard (compliant to quality management system, grounded in scientific facts and/or data, within safety/scope/schedule/cost guidance).
- Understand priority, drive critical path, and monitor secondary critical paths for progress, communicate early any challenges
- Application of statistical and analytical methods such as SPC, SQC, and DOE.
