Medical Device Development Scientist Jobs

Medical bridges clinical development with clinical practice and gains broader knowledge of the healthcare industry.

Manage the ongoing ISR portfolio to ensure timely execution of ISRs.

Effective manage external vendors to deliver projects on time and on budget.

A minimum of 1 - 3 years' experience within the Pharmaceutical Industry.

Experience in leading complex projects and diverse, high performance matrix teams.

Strong interpersonal skills to navigate complex situations and build alignment with key stakeholders.

Keep current with all regulatory guidelines, compendia requirements, and technical innovations.

Strong knowledge of virus, protein and DNA/RNA chemistry

Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMP)

Demonstrated verbal and written skills in technical reports and documents

Experience in separation technologies including multiple modes such as capillary electrophoresis, AUC and mass spectrometric in analyses of biologics

Experience in statistical analysis using JMP or other software

Ensure compliance with regulatory requirements and safety protocols in all laboratory activities, maintaining a strong focus on quality and compliance.

Stay up-to-date with the latest scientific and technological advancements and apply this knowledge to advance product development.

Substantial experience in experimental design, execution, and data analysis within a scientific research and development environment, focusing on process optimization.

Substantial experience developing and ensuring adherence to Standard Operating Procedures (SOPs).

Outstanding analytical, problem-solving, and critical thinking skills, with a proven ability to tackle complex scientific challenges.

Excellent written and verbal communication abilities, including effectively communicating complex scientific concepts to technical and non-technical stakeholders.

Strong interpersonal skills and excellent project management, data analysis, time management and people skills together with a sense of urgency.

Support the quality management system and review for approval other quality system documents as applicable.

In depth knowledge and hands on experience with qPCR, sequencing and standard molecular biology techniques

Manage dynamic timelines, and processes across the product development activities, specifically bioengineering and genome sequencing and cDNA hybridization.

Support all applicable regulations including but not limited to FDA, ISO, IVDR, MDCG, and CMDCAS requirements.

Minimum of 5 years of relevant industry experience and IVD assay development

Knowledge of medical device design controls and risk management including 21CFR Part 820, ISO 13485, and ISO 14971

Performing aspects of Design Control and Risk Management activities

Strong initiative and follow through in executing responsibilities, overcoming obstacles, and balancing multiple priorities effectively

Ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/or teams

3+ Years of experience in a medical device or biotech company

Excellent verbal, written and presentation skills

Working knowledge of FDA requirements as per 21 CFR 820 and ISO 9001, ISO 13485:2003 and ISO 14971:2007 is strongly preferred.

Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety.

Apply strong problem-solving skills to find solutions to complex problems.

Manage part-time staff as a research leader and mentor for ongoing research projects.

Responsibilities may include other duties as assigned and as requiread

Experience gathering user needs, translating them to technical inputs, developing viable V&V (Design Verification and Validation) plans required.

Minimum of four-years experience in semiconductor, optical/plasmonic and/or magnetic device fabrication

Candidate must be innovative, detail-oriented and have strong oral and written communication skills

Excellent teamwork and people skills are required.

PhD in Engineering, Chemistry, Materials Science, or Physics

Expertise in wafer processes such as lithography, wet etching, ion milling, reactive etching, thin films and CMP

Exposure to wafer-level characterization such as SEM, FIB, TEM, AFM and ellipsometry is desirable

Experience with relevant medical & scientific literature databases and strong medical writing skills to produce quality clinical documents

Preferably 2+ years of experience in a similar role in the Medical Device or Pharma industry

Experience writing MEDDEV 2.7.1 rev 4 and MDR compliant CERs and PMCFs

Experience with research methodology (including clinical investigation design and biostatistics)

Ability to apply statistics into method development and sample analysis; experience with statistical software is a plus

Montana employees are currently excluded from this requirement at this time.

Highly skilled in management of cross-disciplinary project teams.

Provides project management expertise and guidance to accomplish targeted development schedules and milestones.

Knowledge of preclinical, clinical, and regulatory product testing and validation requirements.

Must have normal or corrected vision, and the ability to verbally communicate to upper level management.

Additional graduate business education (MBA) is highly desirable.

Minimum of 3 years of industry experience in designing or developing biomedical products is required.

EDUCATION AND EXPERIENCE YOU’LL BRING

Performs other related duties and responsibilities, on occasion, as assigned.

Strong organizational and follow-up skills, as well as attention to detail.

Some experience with medical device industry preferred.

Experience working in a broader enterprise/cross-division business unit model preferred.

At Abbott, you can have a good job that can grow into a great career. We offer: