Executive / senior industry position
Share this Job
Date: Jun 10, 2019
Company: Boston Scientific
Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
- Prepares and submits written (and oral) communications that describe product design concepts, attributes, performance and project status.
- Areas of involvement include; customer and sales support, regulatory submissions, design history files, device evaluation and testing, manufacturing or supplier support, QC, packaging, operating room support and device complaint evaluation.
- Defines and executes product testing and validation protocols.
- Complete the Design History File documentation for assigned projects as required. Ensures that the design control process is adhered to according to ISO 13485, the MDR and complies with policies, legal and safety obligations.
- Produces new ideas, approaches or insights and creates innovative designs.
- Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by ensuring robust processes and systems are put in place.
- Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analysis, FMEAs in conjunction with other product development team members. May be responsible for risk analyses and FMEAs.
- Collects and analyzes Leads Manufacturing process defect data Product/Process improvement efforts (e.g. scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing the appropriate analysis method(s) to enhance sustaining product design and new product development
- Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.
- Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.
- Develops and improves upon reports existing experience to increase abilities in overall value stream
- Hands on working experience with Mobile Apps (Ios/Android) and/or PC/Web based on Product software
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
Education Requirements/ Qualifications:
Higher level Degree/ Level 8 qualification in Engineering/ Quality/ Science with minimum 7 years’ experience in related industry
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Find similar jobs: