Ref No: AM17979
County Wexford, Republic of Ireland
Competitive salary
R&D Manager - Product Engineering/Sustaining Engineering: County Wexford
This role will provide the opportunity to work within a dynamic R&D group where you will experience diverse technologies across commercialised product lines post-launch and manage a diverse range of teams/engineers across product engineering areas covering MDR related projects, 3rd party manufacturers, product engineering and sustaining activities.
The role will also work as part of a dynamic and growing team, engaging in innovation competitions, BioDesign contests, invention disclosure and patent idea brainstorming etc.
Position Summary:
This position is responsible for the coordination of department and division activities for post-launch maintenance of products, product development and management of assigned departmental personnel.
Key Responsibilities:
Post-launch maintenance of products: co-ordinate and/or direct all R&D sustaining engineering activities including business continuity, change control, continuous improvement, and manufacturing support of assigned products.
The position will oversee products which have been commercialised and projects/activities relating to them to include MDR related projects, 3rd party manufacturers, product engineering and sustaining activities.
Product Development: co-ordinate and/or direct all aspects of product development activity related to a product line, including integration of RA, QA/QE, Operations, Clinical, Marketing, Sales and Packaging Engineering.
Work with Operations and Supply Chain to deliver/maintain product to/in market in line with division and operational goals.
Project Management: create and track project schedules, plan and budget for the development of a new product (or line extension) and assess department priorities.
Make assignments to direct reports to ensure projects and company priorities are met.
Co-ordinate with cross-functional peer and team members, internal and external suppliers and outside professionals to ensure department projects are developed to plan.
Design to Manufacturing Transfer: propose and facilitate product updates to capture design intent and transfer to manufacturing. Co-ordinate and participate in the transfer of new and existing products to manufacturing location(s) in co-ordination with manufacturing transfer leads.
Design: Design, develop and implement product and process improvements of medical devices, translating intangible design inputs into tangible engineering specifications in conjunction with cross-functional team members.
Make and present engineering decisions and provide project status reports.
Lead cross-functional teams in the design of a medical device. Contribute ideas and/or generate intellectual property submissions including but not limited to that for product improvements, development of new products and processes.
Oversee and contribute ideas and/or intellectual property submissions including but not limited to the development of new products and processes.
Process Development: work with R&D engineers and manufacturing teams to develop new processes by understanding key process inputs and outputs, including specification development, vendor selection and negotiation.
Documentation: write and review product development plans, design reviews, technical documents and reports.
Prepare, review and approve verification and validation protocols and reports. Develop and implement department and division procedures/policy.
Test Method Development: oversee the development of clinically relevant test methods that adequately challenge new product design and processes.
Testing: Oversee the planning and execution of qualification activities for new products and processes.
Training: train technicians and engineers on design and process development, and provide input to training of division procedures and policies.
Supervisory/mentoring/coaching: Mentor/coach R&D technicians and engineers through Product Development/Improvement/Maintenance activities.
Supervise/manage various members of a R&D department, conducting performance reviews, recommending salaries and promotions, training, interviewing and hiring decisions, and disciplinary actions.
Fiscal: Create, control, manage a department/project budget (expense and capital expenditure). Create and critique engineering cost analysis. Review and analyse costs to identify and implement cost improvements.
Interested applicants should have:
Degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
At least 7 years' industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (or Master's degree plus minimum 5 years or Ph.D. degree with minimum 4 years' experience). A minimum of 4 years’ experience in a supervisory capacity.
Demonstrated knowledge of development, manufacturing and quality system requirements for medical devices or comparably regulated environment is required.
Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialication; ability to execute validation.
Ability to create and execute project plans and lead cross-functional teams.
Excellent oral and written communication skills, with strong, demonstrated skills in communicating with all levels of technical and operations management.
Strong ability to analyse and use technical data and resources. Proficient in statistic software.
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