Senior Biomedical Engineer required to lead Core Product & Process Development, Materials Characterization, Testing & Failure Analysis with a dynamic medical devices client in Galway. Working with a collaborative team of engineers on site you will work on the design of ground breaking & life-saving medical devices for global markets.
Requirements:
- Bachelor’s Degree in Mechanical, Biomedical Engineering or similar discipline, Masters or Ph.D. level preferred but not essential.
- 8+ years experience in a Medical Device Process and/or Product Development.
- Technical Leadership and/or Project Management Experience.
- Knowledge of Design Verification and Process Validations.
- Good working knowledge of medical device quality & regulatory systems and medical device directives (1S013485 and FDA CFR 820).
- Excellent verbal and written communication skills with good presentation skills (working knowledge of MS PowerPoint).
- Experience of medical device development from concept through to commercialisation.
- Good working knowledge of 3D Modelling packages such as Solidworks and/or Pro Engineer CAD.
- Experience with engineering tools such as DOE, SPC, and using Minitab.
- Working knowledge of biocompatible metal and/or polymer materials.
- Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
- Methodical approach with the capable of initiating and driving change while maintaining compliance effectiveness.
- Knowledge of anatomy and physiology.
- Innovative/Creative Engineer.
- Strong technical writer, excellent documentation skills and attention to detail.
- Highly motivated self-starter with a passion for excellence.
- Able to manage people and work in multi-disciplinary teams displaying good interpersonal skills.
- Able to present ideas and concepts clearly and effectively to all levels of the company.
- Able to manage risk in striving to meet objectives.
- Able to grasp and statistically evaluate data to achieve desired outcomes.
- Must be able to work in a fast paced environment.
Willingness and availability to travel from time to time on company business.
Responsibilities:
- Design, research and development of new product/process through the client’s stage gated development process to achieve the required capacity, quality, and cost requirements.
- Design, development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely and effective manner.
- Contribute to the preparation of project proposals, development project plans, detailed project schedules, product design input requirements and design verification test plans.
- Coordinating problem solving initiatives to establish root cause and implementation of appropriate solutions.
- Develop prototypes which are consistent with the clinical and design requirements of the project.
- Introduce new equipment, materials and technologies.
- Maintain current and accurate records of the iterative design process, trial and error experimental steps documented in the design history file or for R&D grant and tax credit submissions.
- Maintain current working knowledge of the key international standards, regulations and regulatory guidance that govern the medical devices industry, medical electrical equipment and nebuliser devices.
- Creation and maintenance of the Design History File and supporting technical documentation required by client’s design control and manufacturing quality system, including design requirements, product specifications, risk management, test protocols and reports.
- Prepare technical documentation in clear and concise terms in accordance with good engineering practice. Be prepared to represent such documentation in an audit. All client quality system and design history file documentation has the potential for future audit by customer, revenue or regulatory authority.
- Liaise closely with the R&D, Manufacturing, Operations, Quality, Sales and Marketing functions through the product development lifecycle.
- Communicate regular and accurate updates on project deliverables to the project leader and/or client management. Communicate risk of divergence from plan to the project leader.
- Assist in the development of intellectual property generated by development activities.
- Participate, as required in trials with physicians to provide clinically relevant feedback on product designs.
- Ability to liaise with customers, suppliers and external bodies such as state agencies.
- Maintain Project Technical files to comply with Medical Quality Standards.
- Conduct all activities in accordance with client’s Quality Policy.
- Conduct material selection taking into account performance and biocompatibility requirements.
- Participate in supplier selection for device manufacture, tooling and components.
- Manage and drive project tasks to ensure timely completion of project milestones.
- Work closely with cross functional groups to achieve project and company goals.
- Retrospective project reviews to understand lessons learned.
- Other tasks required by your supervisor
Team Management:
- Mentoring, coaching and development of direct reports
- Performance of routine appraisals to deliver best results and to obtain the maximum team performance
- Foster innovation and creativity within the team.
emer@emtechrecruitment.ie
